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

Launched by SUMITOMO PHARMA SWITZERLAND GMBH · Feb 13, 2023

Keywords

ClinConnect Summary

The MYFEMBREE® trial is a study that looks at the effects of a specific treatment called relugolix combination therapy on pregnancy outcomes. This therapy includes three medications: relugolix, estradiol, and norethindrone acetate. The study will use health records to compare the health of babies born to women who took this treatment during pregnancy to those who did not. Researchers aim to understand if this therapy affects the health of the baby or mother in any way.

To be eligible for the study, women must be between 18 and 50 years old and have been diagnosed with a condition that the treatment is meant for, before they became pregnant. The study will include two groups: one group of women who took the treatment at any time during their pregnancy, and another group who did not take the treatment at all during their pregnancy. Participants will not need to visit a clinic specifically for this study, as it relies on already collected health data. It’s also important to note that women who have been exposed to certain harmful substances during pregnancy or who have not had health coverage for at least six months before conception will not be included in the study.

Gender

FEMALE

Eligibility criteria

• 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