The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
, 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
Name: Medical Director
Affiliation: Takeda
Role: STUDY_DIRECTOR