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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05739136
• Other study ID #: MVT-601A-003
• Status: Not yet recruiting
• Start date: January 2025
• Est. completion date: May 2027

Study information

• Verified date: March 2024
• Source: Sumitomo Pharma Switzerland GmbH
• Contact: Clinical Trials at Myovant
• Phone: 650-278-8743
• Email: ClinicalTrials[@]Myovant.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 530
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications
• Pregnancy Related
• Pregnancy, High Risk

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Switzerland GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Congenital Malformation (MCM)	Comparison of rate of MCM between cohorts	Up to 5 years
Secondary	Spontaneous abortion (SAB)	Comparison of rate of SABs between cohorts	Up to 5 years
Secondary	Stillbirth	Comparison of rate of stillbirths between cohorts	Up to 5 years
Secondary	Preterm birth	Comparison of rate of preterm births between cohorts	Up to 5 years
Secondary	Small for gestational age (SGA)	Comparison of rate of SGA between cohorts	Up to 5 years