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Effect of KYG0395 on Primary Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT01588236
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Jiangsu Kanion Pharmaceutical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Drug: KYG0395 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : May 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. The maximum dysmenorrheic pain visual analog scale (VAS) score at the end of 3 treatment cycles compared with baseline [ Time Frame: 9 months ]
  2. The number of days of dysmenorrheic pain per cycle at the end of 3 treatment cycles compared with baseline [ Time Frame: 9 months ]
  3. The maximum dysmenorrheic pain VAS score at the end of a 3-cycle follow-up period compared with baseline [ Time Frame: 9 months ]
  4. 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 ]

Secondary Outcome Measures :
  1. Average daily dysmenorrheic pain VAS score in each cycle [ Time Frame: 9 months ]
  2. Rescue medication consumption in each cycle [ Time Frame: 9 months ]
  3. Accompanying symptoms in each cycle [ Time Frame: 9 months ]
  4. Severity of menstrual bleeding in each cycle [ Time Frame: 9 months ]
  5. 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 ]
  6. Responder rate in each cycle [ Time Frame: 9 months ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588236


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

Responsible Party: Jiangsu Kanion Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01588236     History of Changes
Other Study ID Numbers: GF-2011-001
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015

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