Effect of KYG0395 on Primary Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Kanion Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01588236
First received: April 26, 2012
Last updated: October 5, 2015
Last verified: October 2015
  Purpose
The purpose of this study is to further assess the efficacy, safety and dose-response of KYG0395 in the treatment of primary dysmenorrhea.

Condition Intervention Phase
Primary Dysmenorrhea
Drug: KYG0395
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Jiangsu Kanion Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • The maximum dysmenorrheic pain visual analog scale (VAS) score at the end of 3 treatment cycles compared with baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • The number of days of dysmenorrheic pain per cycle at the end of 3 treatment cycles compared with baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • The maximum dysmenorrheic pain VAS score at the end of a 3-cycle follow-up period compared with baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • The number of days of dysmenorrheic pain per cycle at the end of a 3-cycle follow-up period compared with baseline [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average daily dysmenorrheic pain VAS score in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Rescue medication consumption in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Accompanying symptoms in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Severity of menstrual bleeding in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Subject's overall satisfaction at the end of the 3 treatment cycles and at the end of the 3-cycle follow-up period [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Responder rate in each cycle [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: May 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KYG0395 (high dose group) Drug: KYG0395
3 KYG0395 capsules tid (morning, midday, and evening)
Experimental: KYG0395 (lower dose group) Drug: KYG0395
3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
Placebo Comparator: placebo Drug: placebo
3 capsules of placebo tid (morning, midday, and evening)

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Otherwise healthy female subjects (age between 18 and 35, BMI equals or less than 32),with primary dysmenorrhea for at least 3 consecutive menstrual cycles prior to the study (prior to the start of the baseline cycles) and with VAS score > 70 for the maximum dysmenorrheic pain or VAS score > 40 for the average daily dysmenorrheic pain of the last menstrual cycle.

Exclusion Criteria:

  • Known or suspected to have secondary dysmenorrhea due to pelvic inflammation, endometriosis, uterine myomata, ovarian pathological changes, or other pelvic diseases.
  • Pregnant or trying to conceive during the study. Recent delivery, abortion, or lactation within 3 menstrual cycles before the start of treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588236

  Show 23 Study Locations
Sponsors and Collaborators
Jiangsu Kanion Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Jiangsu Kanion Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01588236     History of Changes
Other Study ID Numbers: GF-2011-001 
Study First Received: April 26, 2012
Last Updated: October 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pain
Pathologic Processes
Pelvic Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on February 08, 2016