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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sumitomo Pharma Switzerland GmbH |
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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