Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis (PETAL)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00437658 |
|
Recruitment Status :
Completed
First Posted : February 21, 2007
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Endometriosis | Drug: Elagolix Drug: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) Drug: Placebo to Elagolix Drug: Placebo to DMPA-SC | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 252 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Randomized, Double-blind, Active-controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis |
| Actual Study Start Date : | December 11, 2006 |
| Actual Primary Completion Date : | November 24, 2008 |
| Actual Study Completion Date : | November 24, 2008 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Elagolix 75 mg BID
Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
|
Drug: Elagolix
Provided as tablets for oral administration
Other Names:
Drug: Placebo to DMPA-SC Matching placebo for subcutaneous injection in a pre-filled syringe |
|
Experimental: Elagolix 150 mg QD
Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12.
|
Drug: Elagolix
Provided as tablets for oral administration
Other Names:
Drug: Placebo to DMPA-SC Matching placebo for subcutaneous injection in a pre-filled syringe |
|
Active Comparator: DMPA-SC
Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.
|
Drug: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC)
Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.
Other Name: depo-subQ provera 104™ Drug: Placebo to Elagolix Matching placebo tablets for oral administration |
- Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 [ Time Frame: Baseline and week 24 ]Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.
- Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24 [ Time Frame: Baseline and week 24 ]Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24.
- Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48 [ Time Frame: Baseline and weeks 12 and 48 ]Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model.
- Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48 [ Time Frame: Baseline and weeks 12 and 48 ]Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model.
- Change From Baseline in N-telopeptide at Weeks 12, 24 and 48 [ Time Frame: Baseline and weeks 12, 24 and 48 ]Blood samples to determine N-telopeptide concentrations were analyzed by a central laboratory using an enzyme-linked immunosorbent assay (ELISA). Change from baseline in N-telopeptide was analyzed using a one-way ANOVA model.
- Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24 [ Time Frame: Baseline and week 24 ]
The CPSSS consists of 5 components that address dysmenorrhea (pain during menstruation), dyspareunia (painful intercourse), non-menstrual pelvic pain, pelvic tenderness, and pelvic induration (hardening). Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question "Have you had painful menstruation during the last 28 days?".
Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline.
- Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24 [ Time Frame: Baseline and week 24 ]The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question "Have you had pelvic pain during the last 28 days?" Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline.
- Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48 ]
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question "Have you had painful menstruation during the last 28 days?".
Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline.
- Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48 ]The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question "Have you had pelvic pain during the last 28 days?" Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline.
- Change From Baseline in Total CPSSS During the Treatment Period [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.
The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning).
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
- Change From Baseline in Total CPSSS Excluding Dyspareunia During the Treatment Period [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.
The total CPSSS excluding dyspareunia has a maximum possible value of 12 (total score range: 0 to 12, where a lower score indicates less signs and symptoms of endometriosis or better functioning).
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
- Change From Baseline in Dysmenorrhea Component of the CPSSS During the Treatment Period [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
The dysmenorrhea score was based on the participant's response to the question "Have you had painful menstruation during the last 28 days?".
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
- Change From Baseline in Dyspareunia Component of the CPSSS During the Treatment Period [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
The dyspareunia score was based on the participant's response to the question "Have you had painful intercourse during the last 28 days?" Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
- Change From Baseline in Non-menstrual Pelvic Pain Component of the CPSSS During the Treatment Period [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
The non-menstrual pelvic pain score was based on participant's response to the question "Have you had pelvic pain during the last 28 days?".
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
- Change From Baseline in Pelvic Tenderness Component of the CPSSS During the Treatment Period [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Pelvic tenderness was assessed by the investigator based on findings associated with a pelvic examination.
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
- Change From Baseline in Pelvic Induration Component of the CPSSS During the Treatment Period [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Pelvic induration was assessed by the investigator based on findings associated with a pelvic examination.
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
- Change From Baseline in in Monthly Peak Visual Analog Scale (VAS) for Pelvic Pain [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled "no pain" and the right extreme was labeled "worst pain ever felt" scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ''ticking'' the horizontal line on their e-Diary at approximately the same time each day. Monthly peak VAS for pelvic pain was defined as the maximum VAS pain score reported for an individual participant from the previous visit to the day of the current scheduled visit.
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
- Change From Baseline in in Monthly Mean Visual Analog Scale (VAS) for Pelvic Pain [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled "no pain" and the right extreme was labeled "worst pain ever felt" scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ''ticking'' the horizontal line on their e-Diary at approximately the same time each day. Monthly mean VAS for pelvic pain defined as the average of all VAS pain scores reported for an individual participant from the previous visit to the day of the current scheduled visit.
Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.
- Change From Baseline in Endometriosis Health Profile-5 (EHP-5) Pain Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Change From Baseline in EHP-5 Control and Powerlessness Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Change From Baseline in EHP-5 Emotional Well-being Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Change From Baseline in EHP-5 Social Support Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Change From Baseline in EHP-5 Self Image Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Change From Baseline in EHP-5 Work Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Change From Baseline in EHP-5 Relationship With Children Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Change From Baseline in EHP-5 Intercourse Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Change From Baseline in EHP-5 Medical Profession Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Change From Baseline in EHP-5 Treatment Dimension [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:
- A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image
- A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.
Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life.
- Percentage of Participants Using Analgesics During the Treatment Phase [ Time Frame: 24 weeks ]Analgesic use was collected as part of concomitant medications on a case report form that was administered at each scheduled visit.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be female, aged 18 to 49 years, inclusive
- Have a total CPSSS of ≥ 6 at screening and baseline (Day 1) in the following categories: dysmenorrhea, dyspareunia, nonmenstrual pelvic pain, pelvic tenderness and induration. The total score must include a total of at least 2 in each of the categories of dysmenorrhea and nonmenstrual pelvic pain.
- Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within 8 years of the start of screening with recurrent or persistent symptoms.
- Have documented negative mammogram results within 12 months of screening if over the age of 40 years.
- Have menstrual cycles (28 days ±5 days). Assessment of cycle duration should be based on observations in the absence of drugs or conditions that are known to affect the cycle (e.g., oral contraceptives, leuprolide, pregnancy).
- Have a Body Mass Index (BMI) between 18 and 36 kg/m², inclusive.
- Agree to use two forms of nonhormonal contraception (e.g. condom with spermicide) during the study.
Exclusion Criteria:
- Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or have received any of these agents within 6 months of the start of screening.
- Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
- Have been nonresponsive to GnRH agonist or antagonist therapy for the management of endometriosis.
- Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 1 month of the start of screening.
- Have had surgical treatment for endometriosis (laparoscopy) within 1 month of the start of screening.
- Have had a hysterectomy or bilateral oophorectomy.
- Have had prior treatment with NBI-56418.
- Have uterine fibroids or other pelvic lesions ≥ 5 cm in diameter
-
Have any of the following abnormal cervical smear results at screening (based on the 2001 Bethesda System):
- Benign endometrial cells (BEC) present, provided subject has irregular uterine bleeding or is over 40 years old
- Atypical squamous cells of undetermined significance (ASC-US) present, and human papilloma virus (HPV) reflex testing is positive for high risk types or the testing outcome is unknown
- Atypical squamous cells present, and high-grade squamous intraepithelial lesion (ASC-H) cannot be excluded
- Atypical glandular cells of uncertain significance (AGUS/AGC): not otherwise specified (NOS), favor neoplasia (FN), favor endocervical, or favor endometrial origin types
- Low-grade squamous intraepithelial lesion (LSIL) present
- High-grade squamous intraepithelial lesion (HSIL) present
- Adenocarcinoma in situ (AIS) / malignant cells present
- Have BMD with either lumbar spine or femur T-scores below -1.5 at screening as determined by the central DXA facility or have history of pathologic or compression fractures.
- Have been pregnant within 6 months of screening or currently breast feeding
- Are using systemic steroids on a chronic or regular basis within 3 months
- Have unstable medical condition or chronic disease
- Have chronic pelvic pain that is not caused by endometriosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437658
| Study Director: | AbbVie Inc. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT00437658 |
| Other Study ID Numbers: |
NBI-56418-0603 |
| First Posted: | February 21, 2007 Key Record Dates |
| Results First Posted: | October 12, 2018 |
| Last Update Posted: | October 12, 2018 |
| Last Verified: | March 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
|
Endometriosis Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Medroxyprogesterone Acetate Medroxyprogesterone Contraceptives, Oral, Hormonal Contraceptives, Oral |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptives, Oral, Synthetic Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents |