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Clinical Trials in the USA / NCT05739136
Active, not recruiting Observational

MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy

NCT05739136 · tracked via the Priya Life Science USA tracker
Sponsor
Sumitomo Pharma Switzerland GmbH
Phase
Observational
Started
2025-04-30
Last updated
2025-08-01

Condition(s) studied

Pregnancy RelatedPregnancy ComplicationsPregnancy, High Risk

Investigational drug(s) / intervention(s)

Relugolix + Estradiol + Norethindrone AcetateAll Relugolix trials (6) →All Estradiol trials (7) →

Relugolix + Estradiol + Norethindrone Acetate: Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg)

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Major Congenital Malformation (MCM) — Up to 5 years
    Comparison of rate of MCM between cohorts

Trial sites (1)

FacilityCityRegionStatus
SMPA Marlborough Massachusetts

More Sumitomo Pharma Switzerland GmbH trials in the USA

Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring Recruiting
Congenital Athymia Patient Registry Recruiting
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis Recruiting

Other trials for the same condition

Mavacamten Pregnancy Surveillance Program Recruiting
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population Recruiting
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy Recruiting
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy Recruiting
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05739136 on ClinicalTrials.gov ↗ ← All trials in the USA