NCT05739136Active, not recruiting
MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
Source: ClinicalTrials.gov · Last updated 1 Aug 2025
Brief summary (registry, in English)
This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (HCPs). The study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 530 (estimated)
- First submitted
- 13 Feb 2023
- Start date
- 30 Apr 2025
- Primary completion date
- 31 May 2027
- Lead sponsor
- Sumitomo Pharma Switzerland GmbH
- Diseases
- Endometriosis
- NCT number
- NCT05739136
What you commit to
- Study type: Observational
- Planned participants: 530
- From 30 Apr 2025 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \< 6 months of continuous healthcare coverage immediately prior to date of conception
Other
- Exposure to known teratogens during pregnancy
Who the study is looking for
- Woman ≥ 18 and ≤ 50 years of age at time of conception
- Diagnosis of a condition for which relugolix combination therapy is prescribed (diagnosis captured at any time prior to the estimated date of conception)
- Cohort 1
- Exposure to relugolix combination therapy at any time during pregnancy
- Cohort 2
- No exposure to relugolix combination therapy at any time after the estimated date of conception (during pregnancy)
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SMPA Coordinator of this site? Confirm its status | Marlborough | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.