Efficacy of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-40
SponsorApexCPG LLC
About this trial
This study is to evaluate the effects of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.
Eligibility criteria
Qualifiers
Healthy females aged between 25-40 years with a Body Mass Index (BMI) of approximately 25 to 29 kg/m2.
Healthy women with primary dysmenorrhea Grade 2 (measured using Verbal Multi-dimensional scoring system (VMSS)) at least for 1 day in 50 % of menstrual cycles and maximum pain intensity score ≥4 on a 10 cm VAS for at least 3 menstrual cycles before participating in the study.
Subjects with regular menstrual cycles that typically occur between every 21-35 days (menstrual period 3-7 days) in last 6 months.
Subjects with normal pelvic TVS and breast mammogram.
Disqualifiers
Subjects with irregular menstrual cycle (shorter than 21 and longer than 35 days) affecting the treatment and efficacy judgment.
Subjects with secondary dysmenorrhea (menstrual pain associated with conditions such as endometriosis, pelvic inflammatory disease, leiomyomas, Mullerian anomalies, and adenomyosis and interstitial cystitis).
Subjects who are on related medications such as NSAIDs or hormonal contraceptive pills or intrauterine contraceptive devices in the past 3 months.
History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs daily for any conditions.
Trial design
Treatments tested in this trial
- CL25216
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov