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Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy (SERENE)

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ClinicalTrials.gov Identifier: NCT04756037
Recruitment Status : Active, not recruiting
First Posted : February 16, 2021
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharma Switzerland GmbH

Tracking Information
First Submitted Date  ICMJE February 12, 2021
First Posted Date  ICMJE February 16, 2021
Last Update Posted Date March 12, 2024
Actual Study Start Date  ICMJE March 18, 2021
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI) [ Time Frame: 13 consecutive 28-day treatment cycles ]
The At-Risk PI is defined as the number of on treatment pregnancies per 100 women-years of treatment. The At-Risk PI will be calculated on the basis of cycles considered at-risk of pregnancy, that is, consecutive 28-day periods without use of any other contraceptive methods and with affirmed occurrence of vaginal intercourse. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2021)
Contraceptive Efficacy Of Relugolix Combination Therapy As Assessed By The At-Risk Pearl Index (PI) [ Time Frame: 13 consecutive 28-day treatment cycles ]
The At Risk PI is defined as the number of on treatment pregnancies per 100 women-years of treatment. The At-Risk PI will be calculated on the basis of cycles considered at-risk of pregnancy, that is, consecutive 28-day periods without use of any other contraceptive methods and with affirmed occurrence of vaginal intercourse. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
  • Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Modified At-Risk PI [ Time Frame: 13 consecutive 28-day treatment cycles ]
    The Modified At-Risk PI is based on the number of on-treatment pregnancies occurring during cycles without any other contraceptive methods, regardless of occurrence of vaginal intercourse. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.
  • Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Gross PI [ Time Frame: 13 consecutive 28-day treatment cycles ]
    The "typical use" contraceptive efficacy will be assessed using the Gross PI, based on the number of on-treatment pregnancies occurring during all cycles regardless of the use of other contraceptive methods, confirmed vaginal intercourse, or protocol compliance. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.
  • Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Method Failure PI [ Time Frame: 13 consecutive 28-day treatment cycles ]
    The "perfect use" contraceptive efficacy will be assessed using the Method Failure PI, based on the number of on-treatment pregnancies occurring during cycles that are at risk and without major protocol deviations. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.
  • Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Cumulative 1-Year Pregnancy Rates [ Time Frame: 13 consecutive 28-day treatment cycles ]
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 54 Weeks ]
  • Number of Participants Who Do Not Complete 13 Treatment Cycles [ Time Frame: 13 consecutive 28-day treatment cycles ]
  • Percent Change in Bone Mineral Density from Baseline to 6 and 12 Months On-Treatment [ Time Frame: 12 Months On-Treatment or EOT ]
    The percent change in bone mineral density will be measured from baseline to 6- and 12-months on treatment at the lumbar spine (L1-L4), total hip, and femoral neck.
  • Percent Change in Bone Mineral Density from Baseline an 12 Months On-Treatment (or EOT) to 6 and 12 Months Post-Treatment [ Time Frame: 12 Months Post-Treatment Follow-Up ]
    The percent change in bone mineral density will be measured from baseline and 12-months on-treatment (or End-of-Treatment) to 6- and 12-months post-treatment at the lumbar spine (L1-L4), total hip, and femoral neck.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2021)
  • Contraceptive Efficacy Of Relugolix Combination Therapy As Assessed By The Modified At-Risk PI [ Time Frame: 13 consecutive 28-day treatment cycles ]
    The Modified At-Risk PI is based on the number of on-treatment pregnancies occurring during cycles without any other contraceptive methods, regardless of occurrence of vaginal intercourse. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.
  • Contraceptive Efficacy Of Relugolix Combination Therapy As Assessed By The Gross PI [ Time Frame: 13 consecutive 28-day treatment cycles ]
    The "Typical use" contraceptive efficacy will be assessed using the Gross PI, based on the number of on-treatment pregnancies occurring during all cycles regardless of the use of other contraceptive methods, confirmed vaginal intercourse, or protocol compliance. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.
  • Contraceptive Efficacy Of Relugolix Combination Therapy As Assessed By The Method Failure PI [ Time Frame: 13 consecutive 28-day treatment cycles ]
    The "Perfect use" contraceptive efficacy will be assessed using the Method Failure PI, based on the number of on-treatment pregnancies occurring during cycles that are at risk and without major protocol deviations. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.
  • Contraceptive Efficacy Of Relugolix Combination Therapy As Assessed By The Cumulative 1-year Pregnancy Rates [ Time Frame: 13 consecutive 28-day treatment cycles ]
  • Incidence Of Treatment-emergent Adverse Events [ Time Frame: 54 Weeks ]
  • Number Of Participants Who Do Not Complete 13 Treatment Cycles [ Time Frame: 13 consecutive 28-day treatment cycles ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy
Official Title  ICMJE A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk for Pregnancy
Brief Summary The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
Detailed Description This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams [mg], estradiol [E2] 1 mg, and norethindrone acetate [NETA] 0.5 mg).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Contraception
Intervention  ICMJE Drug: Relugolix Combination Therapy
Participants will receive orally 1 fixed-dose combination tablet (relugolix 40 mg/E2 1 mg/NETA 0.5 mg) once daily.
Other Name: Myfembree
Study Arms  ICMJE Experimental: Relugolix/E2/NETA
Participants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).
Intervention: Drug: Relugolix Combination Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2021)
1020
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2021)
900
Estimated Study Completion Date  ICMJE February 2026
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Is a premenopausal woman, 18 to 50 years of age.
  2. Is at risk of pregnancy (that is, having heterosexual intercourse at least once per month) and is seeking contraception.
  3. Has normal, regular menstrual cycles that are between 21 and 35 days in duration.
  4. Has a diagnosis of uterine fibroids or endometriosis meeting either of the following criteria:

    1. Diagnosis of uterine fibroids by confirmation of ultrasound performed in the last 2 years and patient report of heavy menstrual bleeding affecting quality of life.
    2. Diagnosis of endometriosis and has had surgical or direct visualization (laparoscopy or laparotomy) and/or histopathologic confirmation of endometriosis, and the patient reports moderate, severe, or very severe pain during the most recent menses and/or during nonmenstrual portion of the cycle in the prior month
  5. Is willing to use the study intervention as the sole method of contraception for 13 consecutive 28-day treatment cycles and does not intend to use any other form of contraception (for example, condoms).

Key Exclusion Criteria:

  1. Is pregnant, or breastfeeding, or has breastfed in the last year.
  2. Has a known history of infertility or sub-fertility.
  3. Has presence or history of a venous thromboembolic event (for example, deep vein thrombosis, pulmonary embolism), an arterial thrombotic or thromboembolic event (for example, myocardial infarction, stroke, or peripheral arterial), or a transient ischemic attack, angina pectoris, or claudication.
  4. Has a higher risk of arterial, venous thrombotic, or thromboembolic disorders.
  5. Has a history of migraine with aura or focal neurological symptoms.
  6. Has uncontrolled hypertension, diabetes with inadequate control, or multiple cardiovascular risk factors.
  7. Has a history of clinically significant ventricular arrhythmias.
  8. Has clinically significant liver disease, including active viral hepatitis or cirrhosis.
  9. Has a history of pancreatitis associated with severe hypertriglyceridemia.
  10. Has known human immunodeficiency virus (HIV) infection or high risk of contracting HIV.
  11. Has a hepatic hemangioma or has a history of cholestasis with prior estrogen use or during pregnancy.
  12. Has a serious contraindication to pregnancy (for example, a medical condition or use of chronic medication such as isotretinoin or thalidomide).
  13. History of suicidal ideation or behavior, or confirmed "yes" to any question (with exception of non-suicidal self-injurious behavior, unless deemed as an unacceptable risk by the investigator) on the C-SSRS.
  14. Has a bone mineral density Z-score ≤ -2.0 at lumbar spine, femoral neck, or total hip during the screening period.
  15. Has a history of or currently has osteoporosis, or other metabolic bone disease, collagen vascular disease, chronic kidney disease (CKD) stage 3 or greater with glomerular filtration rate (GFR) < 60 mL/min/m2 using Modification of Diet in Renal Disease (MDRD) method, hyperparathyroidism, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, abnormal bone mineral metabolism (eg, hypophosphatemia), or low traumatic (fragility) fracture.
  16. Has used chronic glucocorticoids that are oral, parenteral, inhaled (prednisone equivalents of ≥ 2.5 mg daily for ≥ 3 months) in 12 months prior to the study.
  17. Has known BRCA mutation or other mutation associated with increased risk of breast cancer.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04756037
Other Study ID Numbers  ICMJE MVT-601-050
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sumitomo Pharma Switzerland GmbH
Original Responsible Party Myovant Sciences GmbH
Current Study Sponsor  ICMJE Sumitomo Pharma Switzerland GmbH
Original Study Sponsor  ICMJE Myovant Sciences GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sumitomo Pharma Switzerland GmbH
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP