Pregnancy RelatedNCT05739123
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
An observational study of Pregnancy Related and Pregnancy Complications, run by Sumitomo Pharma Switzerland GmbH at 1 site in United States.
Trial summary
The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
- What is being tested?
- Relugolix-Containing Product
- How many people
- 728 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to May 2033
- How long will I take part?
- 12 Months
- 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 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include 2 cohorts of pregnant women: one cohort exposed to relugolix-containing therapy and one cohort of women with conditions for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix-containing therapy.
Who may be able to join
- Woman of any age
- Currently or recently pregnant
- Consent to participate
- Authorization for her HCP(s) to provide data to the registry
- Cohort 1
- Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy
- Cohort 2
- Diagnosis of a condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy
Who cannot join
- The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:
- Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)
- Exposure to known teratogens and/or investigational medications during pregnancy
- Lost to follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Myovant Medical Monitor Study Director contact
United States1 site, 1 recruiting
- Recruiting
PPD
Wilmington, North Carolina, 28401
Ronna L Chan, PH.D., M.P.H., 919-270-6678
Ronna L Chan, PH.D, M.P.H.
About this study
The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.
Read the detailed description
The outcomes of interest include major congenital malformation (MCM; primary outcome), minor congenital malformation, spontaneous abortion (SAB), stillbirth, elective termination, small for gestational age (SGA), preterm birth, postnatal growth deficiency, and infant developmental deficiency.
Pregnancy outcomes will be assessed throughout pregnancy, with data collection occurring at enrollment, the end of the second trimester, and pregnancy outcome. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery. Enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable, will serve as data reporters to the registry.
The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during the course of medical care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry.
- Being tested
- Relugolix-Containing Product
- 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-Containing ProductDrug
Also called TAK-385, T-1331285, RVT-601, MVT-601
Any relugolix-containing therapy
| Study group | Role | What they receive |
|---|---|---|
| Exposed Cohort | Pregnant women who are exposed to relugolix-containing therapy at any time during pregnancy Receives: Drug: Relugolix-Containing Product | |
| Unexposed Cohort | Pregnant women with conditions for which relugolix-containing therapy may be prescribed for indications that are approved or under phase 3 development and who are not exposed to relugolix-containing 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 10 years
Secondary outcomes (8)
Minor congenital malformations
Comparison of rate of minor congenital malformations between cohorts
Measured: Up to 10 years
Spontaneous abortion (SAB)
Comparison of rate of SABs between cohorts
Measured: Up to 10 years
Stillbirth
Comparison of rate of stillbirths between cohorts
Measured: Up to 10 years
Elective termination
Comparison of rate of elective terminations between cohorts
Measured: Up to 10 years
Preterm birth
Comparison of rate of preterm births between cohorts
Measured: Up to 10 years
Small for gestational age (SGA)
Comparison of rate of SGA between cohorts
Measured: Up to 10 years
Postnatal growth deficiency
Comparison of rate of postnatal growth deficiency between cohorts
Measured: Up to 10 years
Infant developmental deficiency
Comparison of rate of infant developmental deficiency between cohorts
Measured: Up to 10 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 start8 May 2023
- Primary completionMay 2033 (estimated)
- Study completionMay 2033 (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
- Prospective
- Enrolment
- 728 participants (estimated)
- Target duration
- 12 Months
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
- NCT05739123
- Sponsor's protocol ID
- MVT-601A-002
- Status last verified
- Aug 2025
- First submitted
- 13 Feb 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT05739123
- Acronym / sponsor ID
- MVT-601A-002
- Keywords
- Relugolix, Uterine Fibroids, Endometriosis, Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Sumitomo Pharma Switzerland GmbHIndustry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- May 2033 (estimated)
- Study completion
- May 2033 (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.
The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.
Detailed description
The outcomes of interest include major congenital malformation (MCM; primary outcome), minor congenital malformation, spontaneous abortion (SAB), stillbirth, elective termination, small for gestational age (SGA), preterm birth, postnatal growth deficiency, and infant developmental deficiency.
Pregnancy outcomes will be assessed throughout pregnancy, with data collection occurring at enrollment, the end of the second trimester, and pregnancy outcome. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery. Enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable, will serve as data reporters to the registry.
The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during the course of medical care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Cohort | – | Drug: Relugolix-Containing ProductPregnant women who are exposed to relugolix-containing therapy at any time during pregnancy |
| Unexposed Cohort | – | –Pregnant women with conditions for which relugolix-containing therapy may be prescribed for indications that are approved or under phase 3 development and who are not exposed to relugolix-containing therapy at any time during pregnancy |
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include 2 cohorts of pregnant women: one cohort exposed to relugolix-containing therapy and one cohort of women with conditions for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix-containing therapy.
Key inclusion criteria (8 listed)
- Woman of any age
- Currently or recently pregnant
- Consent to participate
- Authorization for her HCP(s) to provide data to the registry
- Cohort 1
Key exclusion criteria (4 listed)
- The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:
- Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)
- Exposure to known teratogens and/or investigational medications during pregnancy
- Lost to follow-up
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-Containing ProductAlso: TAK-385, T-1331285, RVT-601, MVT-601Any relugolix-containing therapy | Drug | Exposed Cohort |
Primary outcome
Major Congenital Malformation (MCM)
Time frame: Up to 10 years
Comparison of rate of MCM between cohorts
8 secondary outcomes
Minor congenital malformations
Time frame: Up to 10 years
Spontaneous abortion (SAB)
Time frame: Up to 10 years
Stillbirth
Time frame: Up to 10 years
Elective termination
Time frame: Up to 10 years
Preterm birth
Time frame: Up to 10 years
Small for gestational age (SGA)
Time frame: Up to 10 years
Postnatal growth deficiency
Time frame: Up to 10 years
Infant developmental deficiency
Time frame: Up to 10 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 19 Aug 2025.
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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.
Myovant Medical Monitor Study Director contact
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 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?
Contact Clinical Trials at Myovant (650-278-8743, ClinicalTrials@Myovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Congenital Malformation (MCM) (time frame: Up to 10 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 19 Aug 2025.