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

Part of paid clinical trials in Marlborough, Massachusetts.

Sponsor
Sumitomo Pharma Switzerland GmbH
Study ID
NCT05739136
Status
Active Not Recruiting

Conditions

  • Pregnancy Complications
  • Pregnancy Related
  • Pregnancy, High Risk

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
530 participants (estimated)

Arms

  • Arm: Exposed Cohort
    Pregnant women with conditions for which relugolix combination therapy is prescribed, who are exposed to relugolix combination therapy at any time during pregnancy
  • Arm: Unexposed Cohort
    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 Outcome Measure

Major Congenital Malformation (MCM) [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
SMPAMarlboroughMassachusetts01752-

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By research site
SMPA· Marlborough, MA

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