Active — Not RecruitingPhase 3

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

United States1,020 participantsStarted 2021-03-18

Plain-language summary

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

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Is pregnant, or breastfeeding, or has breastfed in the last year.
✕. Has a known history of infertility or sub-fertility.
✕. 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.
✕. Has a higher risk of arterial, venous thrombotic, or thromboembolic disorders.
✕. Has a history of migraine with aura or focal neurological symptoms.
✕. Has uncontrolled hypertension, diabetes with inadequate control, or multiple cardiovascular risk factors.
✕. Has a history of clinically significant ventricular arrhythmias.
✕. Has clinically significant liver disease, including active viral hepatitis or cirrhosis.

Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI)

Timeframe: 13 consecutive 28-day treatment cycles

NCT IDNCT04756037

SponsorSumitomo Pharma Switzerland GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-18

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Is pregnant, or breastfeeding, or has breastfed in the last year.
✕. Has a known history of infertility or sub-fertility.
✕. 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.
✕. Has a higher risk of arterial, venous thrombotic, or thromboembolic disorders.
✕. Has a history of migraine with aura or focal neurological symptoms.
✕. Has uncontrolled hypertension, diabetes with inadequate control, or multiple cardiovascular risk factors.
✕. Has a history of clinically significant ventricular arrhythmias.
✕. Has clinically significant liver disease, including active viral hepatitis or cirrhosis.