Hansoh BioMedical R&D Company
A randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HS-10384 in postmenopausal women suffering from vasomotor symptoms.
Vasomotor Symptoms
HS-10384 tablet Dose 1
HS-10384 tablet Dose 2
HS-10384-matched placebo tablets
Phase 2
The phase 2 study is consisted with 2 doses. The aim is to detect the efficacy, safety, pharmacokinetics and pharmacodynamics characteristics of HS-10384 in participants with vasomotor symptoms.
Study Type : | Interventional |
Estimated Enrollment : | 195 participants |
Masking : | Double |
Primary Purpose : | Treatment |
Official Title : | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of HS-10384 in Postmenopausal Women Suffering From Vasomotor Symptoms (Hot Flashes) |
Actual Study Start Date : | May 30, 2024 |
Estimated Primary Completion Date : | June 30, 2025 |
Estimated Study Completion Date : | September 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: HS-10384 Dose 1 Dose level 1 of HS-10384 |
Drug: HS-10384 tablet Dose 1 |
Experimental: HS-10384 Dose 2 Dose level 2 of HS-10384 |
Drug: HS-10384-matched placebo tablets |
Placebo Comparator: Placebo |
Drug: HS-10384 tablet Dose 2 |
Ages Eligible for Study: | 40 Years to 65 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Chinese Academy of Medical Sciences (CAMS)Peking Union Medical College (PUMC)
Shanghai, Shanghai, China, 100032