Clinical trial · Observational
MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
NCT05739136CI-TRIAL-00092931active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pregnancy Complications | — | UNRESOLVED | — |
| Pregnancy, High Risk | — | UNRESOLVED | — |
| Pregnancy Related | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Relugolix + Estradiol + Norethindrone Acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Exposed Cohort
- description
- Pregnant women with conditions for which relugolix combination therapy is prescribed, who are exposed to relugolix combination therapy at any time during pregnancy
- interventionNames
- Drug: Relugolix + Estradiol + Norethindrone Acetate
- label
- Unexposed Cohort
- description
- Pregnant women with conditions for which relugolix combination therapy could be prescribed, who are not exposed to relugolix combination therapy at any time during pregnancy
Primary outcomes (1)
- measure
- Major Congenital Malformation (MCM)
- timeFrame
- Up to 5 years
- description
- Comparison of rate of MCM between cohorts
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * Exposure to known teratogens during pregnancy * \< 6 months of continuous healthcare coverage immediately prior to date of conception
References
Publications (0)
Data not yet available
No reference posted for this study.