Pregnancy RelatedNCT05739136
MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
An observational study of Pregnancy Related and Pregnancy Complications, run by Sumitomo Pharma Switzerland GmbH at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
- What is being tested?
- Relugolix + Estradiol + Norethindrone Acetate
- How many people
- 530 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will include 2 cohorts: The exposed cohort will include pregnant women with conditions for which relugolix combination therapy is prescribed and who are exposed to relugolix combination therapy at any time during pregnancy. The unexposed cohort will include pregnant women with conditions for which relugolix combination therapy could be prescribed and who are not exposed to relugolix combination therapy at any time during pregnancy.
Who may be able to join
- 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)
Who cannot join
- Exposure to known teratogens during pregnancy
- < 6 months of continuous healthcare coverage immediately prior to date of conception
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- Relugolix + Estradiol + Norethindrone Acetate
- Keywords
- Relugolix, Uterine Fibroids, Endometriosis, Pregnancy
- Medical subject headings
- Pregnancy Complications, Leiomyoma, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relugolix + Estradiol + Norethindrone AcetateDrug
Also called MVT-601, MVT-601A, MYFEMBREE
Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg)
| Study group | Role | What they receive |
|---|---|---|
| Exposed Cohort | Pregnant women with conditions for which relugolix combination therapy is prescribed, who are exposed to relugolix combination therapy at any time during pregnancy Receives: Drug: Relugolix + Estradiol + Norethindrone Acetate | |
| Unexposed Cohort | Pregnant women with conditions for which relugolix combination therapy could be prescribed, who are not exposed to relugolix combination therapy at any time during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Congenital Malformation (MCM)
Comparison of rate of MCM between cohorts
Measured: Up to 5 years
Secondary outcomes (4)
Spontaneous abortion (SAB)
Comparison of rate of SABs between cohorts
Measured: Up to 5 years
Stillbirth
Comparison of rate of stillbirths between cohorts
Measured: Up to 5 years
Preterm birth
Comparison of rate of preterm births between cohorts
Measured: Up to 5 years
Small for gestational age (SGA)
Comparison of rate of SGA between cohorts
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start30 Apr 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Switzerland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739136
- Sponsor's protocol ID
- MVT-601A-003
- Status last verified
- Jul 2025
- First submitted
- 13 Feb 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
- ClinicalTrials.gov ID
- NCT05739136
- Acronym / sponsor ID
- MVT-601A-003
- Keywords
- Relugolix, Uterine Fibroids, Endometriosis, Pregnancy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Sumitomo Pharma Switzerland GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Cohort | – | Drug: Relugolix + Estradiol + Norethindrone AcetatePregnant women with conditions for which relugolix combination therapy is prescribed, who are exposed to relugolix combination therapy at any time during pregnancy |
| Unexposed Cohort | – | –Pregnant women with conditions for which relugolix combination therapy could be prescribed, who are not exposed to relugolix combination therapy at any time during pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will include 2 cohorts: The exposed cohort will include pregnant women with conditions for which relugolix combination therapy is prescribed and who are exposed to relugolix combination therapy at any time during pregnancy. The unexposed cohort will include pregnant women with conditions for which relugolix combination therapy could be prescribed and who are not exposed to relugolix combination therapy at any time during pregnancy.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Exposure to known teratogens during pregnancy
- < 6 months of continuous healthcare coverage immediately prior to date of conception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relugolix + Estradiol + Norethindrone AcetateAlso: MVT-601, MVT-601A, MYFEMBREERelugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg) | Drug | Exposed Cohort |
Primary outcome
Major Congenital Malformation (MCM)
Time frame: Up to 5 years
Comparison of rate of MCM between cohorts
4 secondary outcomes
Spontaneous abortion (SAB)
Time frame: Up to 5 years
Stillbirth
Time frame: Up to 5 years
Preterm birth
Time frame: Up to 5 years
Small for gestational age (SGA)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Pregnancy Complications, run by Sumitomo Pharma Switzerland GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Congenital Malformation (MCM) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.