Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

A Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) in the treatment of uterine fibroids

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221550

Enrollment

216

Registered

2011-08-29

Start date

2011-08-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine fibroids

Interventions

investigational material(s) Generic name etc : TAK-385 INN of investigational material : Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Adm

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma. 2.The participant is a premenopausal woman. 3.The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography. 4.The participant has experienced regular menstrual cycles. 5.The participant is diagnosed as menorrhagia.

Exclusion criteria

Exclusion criteria: 1.Participants with a screening Hb 1.5 times the upper limit of normal (ULN)

Design outcomes

Primary

Measure	Time frame
Decrease in menstrual blood loss Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC). Timeframe:Week 12	—

Secondary

Measure	Time frame
(1)Decrease in menstrual blood loss, amenorrhea, change in menstrual blood loss (2)Myoma and uterine volumes (3)Hemoglobin (Hb) concentration in blood (1)These parameters will be measured using the PBAC. (2)Volumes will be measured by transvaginal sonography. (3)Concentration will be determined by clinical laboratory tests. Timeframe:Pre-treatment period, treatment period	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026