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

Sponsor

Myovant Sciences GmbH (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05739136

Collaborator

(none)

530

Enrollment

50.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Pregnancy Complications Pregnancy, High Risk	Drug: Relugolix + Estradiol + Norethindrone Acetate

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

530 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

May 1, 2027

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Relugolix + Estradiol + Norethindrone Acetate Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg) Other Names: MVT-601 MVT-601A MYFEMBREE
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

Arm

Intervention/Treatment

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

Drug: Relugolix + Estradiol + Norethindrone Acetate

Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg)

Other Names:

MVT-601

MVT-601A

MYFEMBREE

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

Outcome Measures

Primary Outcome Measures

Major Congenital Malformation (MCM) [Up to 5 years]
Comparison of rate of MCM between cohorts

Secondary Outcome Measures

Spontaneous abortion (SAB) [Up to 5 years]
Comparison of rate of SABs between cohorts
Stillbirth [Up to 5 years]
Comparison of rate of stillbirths between cohorts
Preterm birth [Up to 5 years]
Comparison of rate of preterm births between cohorts
Small for gestational age (SGA) [Up to 5 years]
Comparison of rate of SGA between cohorts

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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