Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life
ConditionMenstrual Discomfort
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-35
SponsorEetho Brands, Inc
About this trial
The purpose of this study is to evaluate the efficacy of CL22205 to improve menstrual discomfort and quality of life in oligomenorrheic female subjects.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 a special diet for the past 3 months, taking drugs affecting insulin sensitivity or lipid and hormonal profiles, including glucocorticoids, ovulation-stimulating drugs, anti-obesity, anti-diabetes, anti-hypertensive, anti-estrogenic, anti-androgenic during the last 3 months (except the usual drugs of the subjects).
Trial design
Treatments tested in this trial
- CL22205
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov