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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05739136
Other study ID # MVT-601A-003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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