Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life (NCT06760988) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life
80 participantsStarted 2025-02-24
Plain-language summary
The purpose of this study is to evaluate the efficacy of CL22205 to improve menstrual discomfort and quality of life in oligomenorrheic female subjects.
Who can participate
Age range25 Years – 35 Years
SexFEMALE
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Inclusion Criteria:
* Oligomenorrheic females (Menstrual cycle duration between 36-45 days), aged between 25 and 35 years and with a Body Mass Index (BMI) between 20 to 29.9 kg/m2.
* Subjects with maximum pain intensity ≥40 mm on a 100 mm VAS for at least 2 menstrual cycles before participating in the study.
* Subjects with normal thyroid profile.
* Subjects who are non-smokers and non-alcohol user.
* Subject understands the study procedures and provides signed informed consent to participate in the study.
* Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study.
* Normal vital signs, including electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion Criteria:
* History of any gynaecological disorders which effects the study indication.
* 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 on a daily basis for any conditions.
* Subjects who had any hormonal therapy, metformin or any other herbal products in the past 3 months.
* Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushing's syndrome and congenital adrenal hyperplasia, following …
What they're measuring
1
Change from baseline to the end of the study period in: The Menstrual Symptoms Questionnaire (MSQ) scores
Timeframe: Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)