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

Sumitomo Pharma

Status: Active, not recruiting

Conditions: Pregnancy Complications; Pregnancy Related; Pregnancy, High Risk

Treatments: Drug: Relugolix + Estradiol + Norethindrone Acetate

Study type: Observational

Funder types: Industry

Identifiers

NCT05739136

MVT-601A-003

Details and patient eligibility

About

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.

Full description

The study will identify pregnant women exposed to relugolix combination therapy during pregnancy from a United States (US) administrative claims database. The primary outcome measure is major congenital malformations (MCMs) among linked live births. Secondary outcome measures include spontaneous abortion (SAB), stillbirth, small size for gestational age (SGA), and preterm birth. Infants of pregnancies with linked live birth outcomes will be followed up to 12 months of age for identification of MCMs. Anticipated enrollment is 530 live births.

Enrollment: 530 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

530 participants in 2 patient groups

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

Treatment:

Drug: Relugolix + Estradiol + Norethindrone Acetate

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