New daily pill could ease heavy periods from fibroids
NCT ID NCT06671548
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily pill called relugolix can safely reduce heavy menstrual bleeding in women with uterine fibroids. About 120 premenopausal women will receive either relugolix or a placebo for several weeks. The main goal is to see if the drug lowers blood loss to near-normal levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2024
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Premenopausal female aged 18 or older * Diagnosis of uterine fibroids confirmed by transvaginal/rectal ultrasound during the screening period * Heavy menstrual bleeding caused by uterine fibroids * Breast ultrasound results during the screening period meet the BI-RADS classification of 1 to 3 * Able to understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing Exclusion Criteria: * History of bilateral oophorectomy, or planned to undergo hysterectomy, bilateral oophorectomy, or other surgical procedures during the study period. * Previous treatment with gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonists for uterine fibroids has failed. * History of or current osteoporosis or other metabolic bone disease. * History of malignant tumor within 5 years prior to screening, except for cured skin cancer, basal cell carcinoma, and other localized malignant tumors. * History of drug abuse, alcohol abuse, or drug dependence within 2 years prior to screening. * Presence of an in situ copper intrauterine device (IUD) or a progestin-containing IUD implant/subdermal contraceptive implant during the screening period; subjects who can remove the IUD/subdermal contraceptive implant at least 1 month before enrollment may be allowed to participate. * Baseline bone mineral density Z-score of \< -2.0 at the lumbar spine, total hip, or femoral neck during the screening period. * Any other factors that the investigator deems unsuitable for participation in this trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Heavy menstrual bleeding are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Peking Union Medical College Hospital
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can big data improve safety in gynecologic surgery?
- Can a Double-Wall bag stop leaks during keyhole fibroid surgery?
- Can watching videos before surgery calm nerves?
- A drug that may curb bleeding during fibroid surgery faces its first big test
- Vitamin cocktail may shrink fibroids, reduce surgery need
- Stiffness check could boost fibroid treatment success