Effect of KYG0395 on Primary Dysmenorrhea

NCT01588236 | Completed Phase 2 Results

• 1 other identifier: GF-2011-001
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 23

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.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (4)

• The Change From Baseline to the End of Treatment Period in Maximum Dysmenorrheic Pain VAS Score

  VAS is represented by a straight line with extreme limits: from "no pain" and an associated image of a happy face at the left endpoint to "unbearable pain" and an associated image of an unhappy face at the right endpoint. The left endpoint is the minimum pain score of zero while the right endpoint is the maximum pain score of 100. The dysmenorrheic pain (lower abdominal cramping pain) that usually occurs just before and/or during menstruation was measured in this study using a The Visual Analogue Scale (VAS). Pain was assessed during 9 menstrual cycles from the beginning of the screening to the end of follow-up.

  Baseline and end of treatment (6 months)

• The Change From Baseline in Number of Days With Dysmenorrheic Pain at the End of Treatment

  The change from baseline in number of days with dysmenorrheic pain at the end of 3 treatment cycles

  Baseline and end of treatment (6 months)

• The Change From Baseline to the End of Follow-up Period in the Maximum VAS Score

  VAS is represented by a straight line with extreme limits: from "no pain" and an associated image of a happy face at the left endpoint to "unbearable pain" and an associated image of an unhappy face at the right endpoint. The left endpoint is the minimum pain score of zero while the right endpoint is the maximum pain score of 100. The dysmenorrheic pain (lower abdominal cramping pain) that usually occurs just before and/or during menstruation was measured in this study using a The Visual Analogue Scale (VAS). Pain was assessed during 9 menstrual cycles from the beginning of the screening to the end of follow-up.

  Baseline and end of follow-up (9 months)

• The Number of Days of Dysmenorrheic Pain at the End of Follow-up Period Compared With Baseline

  The change from baseline in the number of days with dysmenorrheic pain at the end of a 3-cycle follow-up period

  Baseline and end of follow-up (9 months)

Secondary Outcomes (3)

• Average Daily Dysmenorrheic Pain VAS Score at the End of Treatment and Follow-up Period

  Baseline, end of treatment (6 months) and end of follow-up (9 months)

• Rescue Medication Consumption at the End of Treatment and Follow-up Period

  Baseline, end of treatment (6 months) and end of follow-up (9 months)

• Subject's Overall Satisfaction at the End of the 3-cycle Follow-up Period

  Base line and end of follow-up (9 months)

Study Arms (3)

high dose KYG0395

EXPERIMENTAL

Patients received high dose KYG0395 capsule (tid)

Drug: high dose KYG0395

lower dose KYG0395

EXPERIMENTAL

Patients received lower dose KYG0395 capsule (bid)

Drug: lower dose KYG0395

placebo

PLACEBO COMPARATOR

Patients received placebo (tid)

Drug: Placebo

Interventions

high dose KYG0395 DRUG

3 KYG0395 capsules tid (morning, midday, and evening)

Also known as: KYG0395 high dose

high dose KYG0395

lower dose KYG0395 DRUG

3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)

Also known as: KYG0395 low dose

lower dose KYG0395

Placebo DRUG

3 capsules of placebo tid (morning, midday, and evening)

Also known as: Placebo oral capsule

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Reviewed and signed the ICF.
• Female between the ages of 18 and 35 (inclusive) at the time of signing the ICF.
• Otherwise healthy female subjects 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.
• Recent (last 6 months) history of regular menstrual cycles. Regular menstrual cycle meant the period of the cycle fell in the range of 21 to 35 days.
• No contraceptive injection, implant, or intrauterine device within 6 months prior to the study and willing not to use any of them during the entire study period. Subject agreed to the use of a highly effective method of contraception throughout the study including:
• day regimens of combined oral contraceptives, patches, or rings
• Bilateral tubal sterilization
• Partner vasectomy
• Condoms and spermicide
• Diaphragm and spermicide At the discretion of the investigator, total abstinence was permitted as a method where age, lifestyle, or sexual orientation of the subject ensured compliance. If the subject was taking combined hormonal contraception, it had to be taken for at least 6 months prior to screening and be used throughout the duration of the study without interruption. No more than 50% of enrolled subjects were to be taking combined hormonal contraception.
• Agreed not to use any dietary supplement or alternative medication intended to treat dysmenorrhea and/or its accompanying symptoms during the entire study period.
• Was able to tolerate ibuprofen and willing to use only ibuprofen supplied by the sponsor for this study as a rescue medication.
• Was able to understand and follow the study instructions, to complete the electronic subject diary, and to communicate with the investigator and staff.

You may not qualify if:

• Known or suspected to have secondary dysmenorrhea due to pelvic inflammation, endometriosis, uterine myomata, ovarian pathological changes, or other pelvic diseases.
• Known or suspected to have gastrointestinal or urological conditions that may cause abdominal/pelvic pain, such as colitis, appendicitis, irritable bowel syndrome, cholelithiasis, interstitial cystitis, urocystitis, nephrolithiasis, and other conditions that, according to the investigator's judgment, are not suitable for the study.
• Use of an intrauterine contraceptive device, contraception injection, contraceptive implant, progesterone-only contraceptive pills, or an extended-cycle combined hormonal contraceptive regimen that does not foster cyclic withdrawal bleeding every 28 days within 6 months of screening or during the study.
• Screening pelvic ultrasound findings suggestive of significant pathology including secondary causes of dysmenorrhea such as more than 2 uterine fibroids \>3 cm in diameter, or complex ovarian cysts. At the discretion of the investigator, simple ovarian cysts \<3 cm in diameter or functional ovarian cysts that were deemed to not require follow-up were permitted.
• Obesity: body mass index (BMI) \>32 kg/m2.
• Positive gonorrhea and/or chlamydia test or evidence of other active sexually transmitted disease that, in the investigator's opinion, would make the subject not suitable for the study.
• Known allergy to the study drug, or hypersensitivity to any of the study drug ingredients, or known allergy or intolerance to one or more of the excipients: β cyclodextrin and lactose, and according to the investigator's judgment, the allergy/intolerance was so severe that the subject was not suitable for the study.
• Presence of one or more than one of the following: cerebrovascular disease, cardiovascular disease, pulmonary embolism, coagulopathy, thrombophlebitis, optic neuritis, retinal vein thrombosis, liver tumor, kidney tumor, renal failure, hepatitis, or other serious primary diseases of hepatic, renal or hematopoietic systems and mental disorders that according to the investigator's judgment renders the subject unsuitable for the study; or any chronic disease(s) for which the subject had been taking long term medication, and according to the investigator's judgment was unsuitable for the study. The investigator may have contacted the medical monitor and/or sponsor with questions about whether a subject was suitable for the study.
• Hypertension, defined as sitting blood pressure (BP) systolic \>140 mm Hg or diastolic \>90 mm Hg (repetition of the measurement of BP was permitted to confirm the subject's hypertension condition).
• Pregnant or trying to conceive during the study. Recent delivery, abortion, or lactation within 3 menstrual cycles before the start of treatment.
• Alcoholism or drug abuse within the last 6 months prior to the study.
• Regular use of any concomitant medications that might have confounded efficacy and/or safety assessments including, but not limited to, the following: narcotic, non NSAID, or NSAID analgesics for the treatment of conditions other than dysmenorrhea, psychotropic drugs, antidepressants, sedative hypnotics, sedating antihistamines, muscle relaxants, or tranquilizers. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors were permitted for indications other than pain provided that the subject had been on a stable dose for at least 2 menstrual cycles before providing consent for this study and agreed to remain on a stable dose throughout the course of the study.
• Simultaneous participation in another clinical study or use of any experimental drug or device, or being a subject in another clinical research program within 30 days prior to the screening visit.
• Use of any dietary supplement or alternative medication intended to treat dysmenorrhea or its accompanying symptoms within 30 days prior to the screening visit.
• Major surgery scheduled for the study period.

Sponsors & Collaborators

• Jiangsu Kanion Pharmaceutical Co., Ltd: lead

Study Sites (23)

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72205, United States

Location

Women's Health Care at Frost Street

San Diego, California, 92123, United States

Location

Coastal Connecticut Research

New London, Connecticut, 06320, United States

Location

Atlanta Women's Research Institute, Inc.

Atlanta, Georgia, 30342, United States

Location

Women's Healthcare Associates dba Rosemark WomenCare Specialists

Idaho Falls, Idaho, 83404, United States

Location

Chicago Research Center, Inc.

Chicago, Illinois, 60634, United States

Location

Genesis Clinical Research

Fall River, Massachusetts, 02720, United States

Location

ClinSite

Ann Arbor, Michigan, 48106, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Lawrence OB GYN Associates

Lawrenceville, New Jersey, 08648, United States

Location

The Center for Women's Health and Wellness LLC

Plainsboro, New Jersey, 08536, United States

Location

Suffolk OB-GYN

Port Jefferson, New York, 11777, United States

Location

Lynhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Columbus Center for Women's Health Research

Columbus, Ohio, 43213, United States

Location

Clinical Trials Research Services

Pittsburgh, Pennsylvania, 15206, United States

Location

SC Clinical Research Center, LLC

Columbia, South Carolina, 29201, United States

Location

Dial Research Associates, Inc.

Nashville, Tennessee, 37215, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

Advances in Health

Houston, Texas, 77030, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Women's Clinical Research Center

Seattle, Washington, 98105, United States

Location

Results Point of Contact

• Title: Weiyi Liu, MD
• Organization: Jiangsu Kanion Pharmaceutical Co. Ltd

liuweiyi65@hotmail.com

3016533500

Study Officials

• Xiaoming Song, MD

  Jiangsu Kanion Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 1, 2025
• Results First Posted: March 26, 2019

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)