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Effect of KYG0395 on Primary Dysmenorrhea

NCT01588236 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-10-01

Study results available
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Summary

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

Conditions

  • Primary Dysmenorrhea

Interventions

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)

Sponsors & Collaborators

  • Jiangsu Kanion Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaoming Song, MD · Jiangsu Kanion Pharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588236 on ClinicalTrials.gov