NCT01588236

Effect of KYG0395 on Primary Dysmenorrhea

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Further Assess the Efficacy, Safety and Dose Response of KYG0395 in the Treatment of Primary Dysmenorrhea

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to further assess the efficacy, safety and dose-response of KYG0395 in the treatment of primary dysmenorrhea.

Detailed description

Compare the effect and safety of the investigational drug and placebo on dysmenorrhea in adult otherwise healthy women.

Conditions

• Primary Dysmenorrhea

Interventions

Type	Name	Description
DRUG	high dose KYG0395	3 KYG0395 capsules tid (morning, midday, and evening)
DRUG	lower dose KYG0395	3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
DRUG	Placebo	3 capsules of placebo tid (morning, midday, and evening)

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2012-04-30
• Last updated: 2025-10-01
• Results posted: 2019-03-26

Locations

23 sites across 1 country: United States