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Study of the Contraceptive Efficacy of Relugolix Combination Therapy in Healthy Women Who Are at Risk for Pregnancy (SERENE)

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ClinicalTrials.gov Identifier: NCT04756037
Recruitment Status : Recruiting
First Posted : February 16, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

Brief Summary:
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.

Condition or disease Intervention/treatment Phase
Contraception Drug: Relugolix Combination Therapy Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Single-Arm, Open-Label Study to Evaluate the Contraceptive Efficacy of Relugolix Combination Therapy in Healthy Women 18 to 35 Years of Age Who Are at Risk for Pregnancy
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023

Arm Intervention/treatment
Experimental: Relugolix/E2/NETA
Participants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Contraceptive Efficacy Of Relugolix Combination Therapy As Assessed By The Cumulative 1-year Pregnancy Rates [ Time Frame: 13 consecutive 28-day treatment cycles ]
  5. Incidence Of Treatment-emergent Adverse Events [ Time Frame: 54 Weeks ]
  6. Number Of Participants Who Do Not Complete 13 Treatment Cycles [ Time Frame: 13 consecutive 28-day treatment cycles ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Is a premenopausal woman, 18 to 35 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. 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.
  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 history of migraine with aura or focal neurological symptoms.
  5. Has uncontrolled hypertension, diabetes with inadequate control, or multiple cardiovascular risk factors.
  6. Has clinically significant liver disease.
  7. Has known human immunodeficiency virus (HIV) infection or high risk of contracting HIV.
  8. Has any disease that may worsen under hormonal treatment, such as known gallbladder disease or a hepatic hemangioma.
  9. Has a serious contraindication to pregnancy (for example, a medical condition or use of chronic medication such as isotretinoin or thalidomide).

Information from the National Library of Medicine

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): NCT04756037


Contacts
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Contact: Clinical Trials at Myovant 650-278-8743 ClinicalTrials@Myovant.com
Contact: Myovant Medical Monitor Study Director, Myovant Sciences

Locations
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Sponsors and Collaborators
Myovant Sciences GmbH
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Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT04756037    
Other Study ID Numbers: MVT-601-050
First Posted: February 16, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Myovant Sciences GmbH:
Relugolix
Estradiol
Norethindrone acetate