Primary DysmenorrheaPhase 2NCT01588236

Effect of KYG0395 on Primary Dysmenorrhea

A Phase 2 study testing high dose KYG0395 and lower dose KYG0395 in people with Primary Dysmenorrhea, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: Primary Dysmenorrhea
What is being tested?: high dose KYG0395 and lower dose KYG0395
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 280 participants
Where: 23 sitesUnited States
Study dates: May 2012to Jul 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
No healthy volunteers
Adult

Who may be able to join

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:
28-day regimens of combined oral contraceptives, patches, or rings

Show all 13Show fewer

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.

Who cannot join

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.

Show all 23Show fewer

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.
Known to have a positive human immunodeficiency virus test.
Abnormal Papanicolaou (PAP) test results, except atypical squamous cells of unknown significance with reflex human papillomavirus test negative.
Inability to follow study procedures for any reason, including the following examples: language comprehension, psychiatric illness, or inability to get to the study center.
Had a clinically significant deviation from normal in any of the screening tests or examinations.
Had the presence of all 3 of the following signs and symptoms during the 2 weeks prior to screening.
Reported that her usual urine color was grade 7 or above on the pictorial scale (provided in the GF-2011-001 Special Assessment Guide) and laboratory examination of the color of her urine at screening confirmed this
Reported that she usually had dry stools and had experienced constipation for at least 2 consecutive days
Was noted on the screening examination by the investigator to have a red tongue with a yellow coating (example photograph provided in the GF 2011 001 Special Assessment Guide)

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

ClinSite
Ann Arbor, Michigan, 48106
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, 30342
Benchmark Research
Austin, Texas, 78705
Chicago Research Center, Inc.
Chicago, Illinois, 60634
SC Clinical Research Center, LLC
Columbia, South Carolina, 29201
Columbus Center for Women's Health Research
Columbus, Ohio, 43213
Advanced Research Associates
Corpus Christi, Texas, 78414
Genesis Clinical Research
Fall River, Massachusetts, 02720
Advances in Health
Houston, Texas, 77030
Women's Healthcare Associates dba Rosemark WomenCare Specialists
Idaho Falls, Idaho, 83404
Lawrence OB GYN Associates
Lawrenceville, New Jersey, 08648
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
Montana Medical Research
Missoula, Montana, 59808
Dial Research Associates, Inc.
Nashville, Tennessee, 37215
Coastal Connecticut Research
New London, Connecticut, 06320
Women's Health Research
Phoenix, Arizona, 85015
Clinical Trials Research Services
Pittsburgh, Pennsylvania, 15206
The Center for Women's Health and Wellness LLC
Plainsboro, New Jersey, 08536
Suffolk OB-GYN
Port Jefferson, New York, 11777
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Women's Health Care at Frost Street
San Diego, California, 92123
Women's Clinical Research Center
Seattle, Washington, 98105
Lynhurst Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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

Read the detailed description

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

Conditions: Primary Dysmenorrhea
Being tested: high dose KYG0395, lower dose KYG0395, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high dose KYG0395Drug
Also called KYG0395 high dose
3 KYG0395 capsules tid (morning, midday, and evening)
lower dose KYG0395Drug
Also called KYG0395 low dose
3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
PlaceboDrug
Also called Placebo oral capsule
3 capsules of placebo tid (morning, midday, and evening)

Study groups in NCT01588236
Study group	Role	What they receive
high dose KYG0395	Experimental	Patients received high dose KYG0395 capsule (tid) Receives: Drug: high dose KYG0395
lower dose KYG0395	Experimental	Patients received lower dose KYG0395 capsule (bid) Receives: Drug: lower dose KYG0395
placebo	Placebo comparator	Patients received placebo (tid) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
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.
Measured: 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
The change from baseline to the end of treatment and follow-up period in rescue medication consumption
Measured: 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
The subject's evaluation of overall satisfaction was recorded in the electronic subject diary at the end of the 3 treatment cycles and at the end of the 3-cycle follow-up period (at the end of the day before the subject goes to bed) using the numeric rating scale provided below:
0=None, Not satisfied with the treatment outcome；
1. Mild, Mildly satisfied with the treatment outcome；
2. Most, Mostly satisfied with the treatment outcome；
3. Complete, Completely satisfied with the treatment outcome.
Measured: Base line and end of follow-up (9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Jul 2015

First posted30 Apr 2012 (estimated)
Study startMay 2012
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 280 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01588236
Sponsor's protocol ID: GF-2011-001
Status last verified: Sep 2025
First submitted: 26 Apr 2012
Last updated: 1 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Dysmenorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01588236
Acronym / sponsor ID: GF-2011-001
Conditions: Primary Dysmenorrhea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 280 participants (actual)
Lead sponsor: Jiangsu Kanion Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 30 Apr 2012 (estimated)
Results: Posted 26 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
high dose KYG0395	Experimental	Drug: high dose KYG0395Patients received high dose KYG0395 capsule (tid)
lower dose KYG0395	Experimental	Drug: lower dose KYG0395Patients received lower dose KYG0395 capsule (bid)
placebo	Placebo comparator	Drug: PlaceboPatients received placebo (tid)

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (13 listed)

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:

Key exclusion criteria (23 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
high dose KYG0395Also: KYG0395 high dose3 KYG0395 capsules tid (morning, midday, and evening)	Drug	high dose KYG0395
lower dose KYG0395Also: KYG0395 low dose3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)	Drug	lower dose KYG0395
PlaceboAlso: Placebo oral capsule3 capsules of placebo tid (morning, midday, and evening)	Drug	placebo

Primary outcome

The Change From Baseline to the End of Treatment Period in Maximum Dysmenorrheic Pain VAS Score
Time frame: Baseline and end of treatment (6 months)
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.
The Change From Baseline in Number of Days With Dysmenorrheic Pain at the End of Treatment
Time frame: Baseline and end of treatment (6 months)
The change from baseline in number of days with dysmenorrheic pain at the end of 3 treatment cycles
The Change From Baseline to the End of Follow-up Period in the Maximum VAS Score
Time frame: Baseline and end of follow-up (9 months)
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.
The Number of Days of Dysmenorrheic Pain at the End of Follow-up Period Compared With Baseline
Time frame: Baseline and end of follow-up (9 months)
The change from baseline in the number of days with dysmenorrheic pain at the end of a 3-cycle follow-up period

3 secondary outcomes

Average Daily Dysmenorrheic Pain VAS Score at the End of Treatment and Follow-up Period
Time frame: 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
Time frame: 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
Time frame: Base line and end of follow-up (9 months)

Results and safety

Results posted to the registry on 26 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KYG0395 (High Dose Group)	92	61
KYG0395 (Lower Dose Group)	94	51
Placebo	94	66

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

Time frame: Baseline and end of treatment (6 months). Least squares mean (Standard Error). Unit: units on a scale

Measure	KYG0395 (High Dose Group) n = 81	KYG0395 (Lower Dose Group) n = 77	Placebo n = 80
Value	-19.8 (2.84)	-18.0 (3.07)	-14.4 (2.86)

KYG0395 (High Dose Group) vs KYG0395 (Lower Dose Group) vs Placebo: p >0.05, Mixed Models Analysis

Population analysed: Full analysis set: all subjects who received at least one treatment dose and had one post-baseline assessment

Primary outcome: The Change From Baseline in Number of Days With Dysmenorrheic Pain at the End of Treatment

Time frame: Baseline and end of treatment (6 months). Least squares mean (Standard Error). Unit: days

Measure	KYG0395 (High Dose Group) n = 81	KYG0395 (Lower Dose Group) n = 77	Placebo n = 80
Value	-1.4 (0.17)	-1.3 (0.19)	-1.1 (0.18)

KYG0395 (High Dose Group) vs KYG0395 (Lower Dose Group) vs Placebo: p >0.05, Mixed Models Analysis

Population analysed: Full analysis set: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score

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

Time frame: Baseline and end of follow-up (9 months). Least squares mean (Standard Error). Unit: unit of a scale

Measure	KYG0395 (High Dose Group) n = 81	KYG0395 (Lower Dose Group) n = 77	Placebo n = 80
Value	-22.8 (2.93)	-15.5 (3.21)	-9.8 (2.79)

KYG0395 (High Dose Group) vs KYG0395 (Lower Dose Group) vs Placebo: p <0.01, Mixed Models Analysis

Population analysed: FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score

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

Time frame: Baseline and end of follow-up (9 months). Least squares mean (Standard Error). Unit: days

Measure	KYG0395 (High Dose Group) n = 81	KYG0395 (Lower Dose Group) n = 77	Placebo n = 80
Value	-1.3 (0.19)	-1.5 (0.21)	-1.0 (0.18)

KYG0395 (High Dose Group) vs KYG0395 (Lower Dose Group) vs Placebo: p <0.05, Mixed Models Analysis

Population analysed: FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KYG0395 (High Dose Group)	1 of 88 (1.1%)	23 of 88 (26.1%)	Not reported
KYG0395 (Lower Dose Group)	1 of 90 (1.1%)	25 of 90 (27.8%)	Not reported
Placebo	1 of 91 (1.1%)	35 of 91 (38.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaoming Song, MD study director

Jiangsu Kanion Pharmaceutical Co., Ltd

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing high dose KYG0395 and lower dose KYG0395 in people with Primary Dysmenorrhea, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change From Baseline to the End of Treatment Period in Maximum Dysmenorrheic Pain VAS Score (time frame: Baseline and end of treatment (6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01588236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.