Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT06258902 - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed NCT05487196 - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia Phase 2
Completed NCT03750968 - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects Phase 2
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT06069856 - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06069869 - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Not yet recruiting NCT06079918 - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania Phase 3