Trial record 2 of 2 for:
SC-104
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
|
Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Endometriosis |
Interventions |
Drug: Elagolix Drug: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) Drug: Placebo to Elagolix Drug: Placebo to DMPA-SC |
Enrollment | 252 |
Participant Flow
Recruitment Details | Participants were randomized at 58 centers in the United States. |
Pre-assignment Details | This study consisted of a 24-week treatment period and a 24-week post-treatment period. Participants were randomized in a 1:1:1 ratio to one of three treatment groups. |
Arm/Group Title | Elagolix 150 mg QD | Elagolix 75 mg BID | DMPA-SC |
---|---|---|---|
Arm/Group Description | 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. | 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. | 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. |
Period Title: Treatment Period (24 Weeks) | |||
Started | 84 | 84 | 84 |
Received Study Drug | 84 | 84 | 84 |
Completed | 56 | 62 | 51 |
Not Completed | 28 | 22 | 33 |
Reason Not Completed | |||
Adverse Event | 4 | 7 | 14 |
Non-compliance | 1 | 1 | 4 |
Withdrawal by Subject | 9 | 7 | 7 |
Lack of Efficacy | 4 | 2 | 3 |
Lost to Follow-up | 5 | 4 | 5 |
Sponsor/Investigator Decision | 5 | 1 | 0 |
Period Title: Post-treatment Period (24 Weeks) | |||
Started | 56 | 62 | 51 |
Completed | 32 | 54 | 37 |
Not Completed | 24 | 8 | 14 |
Reason Not Completed | |||
Adverse Event | 1 | 0 | 1 |
Non-compliance | 3 | 0 | 1 |
Withdrawal by Subject | 12 | 6 | 8 |
Lack of Efficacy | 0 | 2 | 2 |
Lost to Follow-up | 5 | 0 | 1 |
Sponsor/Investigator Decision | 3 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Elagolix 150 mg QD | Elagolix 75 mg BID | DMPA-SC | Total | |
---|---|---|---|---|---|
Arm/Group Description | 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. | 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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 84 | 84 | 84 | 252 | |
Baseline Analysis Population Description |
[Not Specified]
|
||||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||
Number Analyzed | 84 participants | 84 participants | 84 participants | 252 participants | |
32.4 (7.5) | 31.4 (6.1) | 30.9 (6.3) | 31.6 (6.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 84 participants | 84 participants | 84 participants | 252 participants | |
Female |
84 100.0%
|
84 100.0%
|
84 100.0%
|
252 100.0%
|
|
Male |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 84 participants | 84 participants | 84 participants | 252 participants | |
Asian |
1 1.2%
|
0 0.0%
|
1 1.2%
|
2 0.8%
|
|
Black |
6 7.1%
|
10 11.9%
|
10 11.9%
|
26 10.3%
|
|
White |
68 81.0%
|
70 83.3%
|
65 77.4%
|
203 80.6%
|
|
Hispanic |
8 9.5%
|
4 4.8%
|
6 7.1%
|
18 7.1%
|
|
American Indian or Alaska Native, Caucasian |
0 0.0%
|
0 0.0%
|
1 1.2%
|
1 0.4%
|
|
Black, Caucasian |
1 1.2%
|
0 0.0%
|
0 0.0%
|
1 0.4%
|
|
Caucasian, Hispanic |
0 0.0%
|
0 0.0%
|
1 1.2%
|
1 0.4%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: | Global Medical Services |
Organization: | AbbVie |
Phone: | 800-633-9110 |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT00437658 |
Other Study ID Numbers: |
NBI-56418-0603 |
First Submitted: | February 16, 2007 |
First Posted: | February 21, 2007 |
Results First Submitted: | August 9, 2018 |
Results First Posted: | October 12, 2018 |
Last Update Posted: | October 12, 2018 |