2026-07-20
critical
Study Status v12
Primary completion pushed: 2027-09-06 → 2028-09-11
Completion pushed: 2027-12-13 → 2028-12-11
2026-06-09
minor
Study Status, Eligibility v11
Eligibility criteria+121 characters
[...] den, with UFS-QOL SSS score of 30 or higher at baseline
Has regularly occurring menstrual periods of ≤ 14 days duration withhad a cycle of 21 to 38 days from the start of one menstrual period untilin the start of the next, by patient history for at leastpast 3 months prior(90 to screeningdays)
Agree to use a non-hormonal or barrier method of contracept [...] a treated by GRNH agonist or antagonist in the last 12 weeks (if injected) or in the last 4 weeks (if oral); or plans to use the above in the next 24 weeks
Currently p [...] iol level <30 pg/mL (consistent with postmenopausal status)
IrregularlyFor time [...] [...]
2026-05-18
notable
Study Status v10
Primary completion pushed: 2027-06-30 → 2027-09-06
Completion pushed: 2027-06-30 → 2027-12-13
2026-04-23
notable
Study Status, Contacts/Locations v9
Primary completion pushed: 2027-01-30 → 2027-06-30
Completion pushed: 2027-04-30 → 2027-06-30
Study sitesdetails revised at 2 of 5 sites
2026-02-02
minor
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 5 sites
Show 7 earlier versions
2025-12-18
minor
Study Status, Contacts/Locations v7
2024-10-22
minor
Study Status, Eligibility v6
Eligibility criteria-27 characters
[...] UFS-QOL SSS score of 30 or higher at baseline
Has regularly- occurring menstrual periods of ≤ 14 days duration with a cy [...] ast 3 months prior to screening
Agree to use a non-hormonal or barrier method of contraception duringwith the study period if at risk for pregnancy (any sexual activity with a non-sterile male partner during the study period (i.e., use of copper IUD is consistent with eligibility)
Exclusion Criteria:
Screening pelvic imaging indicating any leiomyomata ≥810 cm in maximum diameter, or uterine size ≥1416 cm in length (equivalent to 1416 weeks gestation)-note that candidates who [...] [...]
2024-07-25
minor
Study Status, Contacts/Locations v5
Start dateestimated 2024-06-14→confirmed 2024-07-24
Study sites2 entries, revised
University of California, SansSan Francisco
2024-06-05
minor
Study Status v4
Start date2024-05-14→2024-06-14
2024-05-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 2 of 2 sites
2024-05-13
minor
Study Status v2
Completion date2027-06-30→2027-04-30
Start date2024-05-13→2024-05-14
2024-05-02
minor
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Start date2024-03-01→2024-05-13
Eligibility criteria+669 characters
[...] vic pressure or discomfort, urinary or bowel abnormalities, or dyspareunia for the past 3 months
Have at least moderate leiomyomata symptom burden, with UFS-QOL SSS score of at30 leastor 30higher at baseline)
Has regularly-occurring menstrual periods of ≤ 14 days dura [...] gth (equivalent to 14 weeks gestation)-note that candidates withwho exclusively have prior clinical pelvic imaging 12-24 months ago will be excl [...] cm in length, presuming leiomyoma growth of ≥1 cm per year
Screening pelvic imaging indicating only one, sole leiomyoma <2 cm in maximum diameter
Any submucosal leiomyoma that is <50% wit [...] [...]
Secondary endpoints+435 characters
Uterine leiomyoma-related quality of life over 12 weeks of treatment
Total leiomyoma volume over 12 weeks of treatment
Total uterine volume over 12 weeks of treatment
Symptoms of heavy menstrual bleeding
Improvement in Sexual Functioning
Symptoms of pelvic pain
Symptoms of urogenital distress
Effect [...]
Primary endpoints2 to 1 entries
ChangeUterine in fibroidleiomyoma-related symptom severity
Change inover fibroid12 symptomweeks severityof treatment
Study sitescontacts updated at 1 of 2 sites
2023-11-15
minor
Original filing