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Spots Global Cancer Trial Database for A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

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Trial Identification

Brief Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-385 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

Study ID: NCT02655237

Study Description

Brief Summary: The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously \[SC\]/time) in patients with uterine fibroids.

Detailed Description: The drug tested in this study was called Relugolix (TAK-385). Relugolix was tested to treat people who had uterine fibroids. The study enrolled 281 patients. Participants received relugolix placebo and leuprorelin acetate placebo in run in period for 3 to 6 weeks. After run-in period, participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in 1:1 ratio: * Relugolix 40 mg * Leuprorelin 1.88 or 3.75 mg Participants received relugolix tablets once daily along with leuprorelin 1.88 mg or 3.75 mg subcutaneous injection once in 4 weeks for 24 weeks in treatment period. This multi-center trial was conducted in Japan. The overall time to participate in this study was approximately 32 to 40 weeks including run-in period of 3 to 6 weeks and a treatment period of 24 weeks. Participants will make multiple visits to the clinic, and a final visit 4 weeks after last dose of study drug for a follow-up assessment.

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

, Nagoya, Aichi, Japan

, Matsudo, Chiba, Japan

, Kouriyama, Fukushima, Japan

, Ebetsu, Hokkaido, Japan

, Sapporo, Hokkaido, Japan

, Kako-gun, Hyogo, Japan

, Nishinomiya, Hyogo, Japan

, Kawasaki, Kanagawa, Japan

, Yamato, Kanagawa, Japan

, Yokohama, Kanagawa, Japan

, Ibaraki, Osaka, Japan

, Sakai, Osaka, Japan

, Suita, Osaka, Japan

, Yao, Osaka, Japan

, Bunkyo-ku, Tokyo, Japan

, Chiyoda-ku, Tokyo, Japan

, Chuou-ku, Tokyo, Japan

, Minato-ku, Tokyo, Japan

, Setagaya-ku, Tokyo, Japan

, Suginami-ku, Tokyo, Japan

, Taitou-ku, Tokyo, Japan

, Kagoshima, , Japan

, Kyoto, , Japan

, Osaka, , Japan

, Saitama, , Japan

Contact Details

Name: Medical Director

Affiliation: Takeda

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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