Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause
ConditionVasomotor Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorApexCPG LLC
About this trial
This study is to evaluate the effects of CL25216 on vasomotor symptoms in women during Perimenopause. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.
Eligibility criteria
Qualifiers
Healthy overweight women (BMI: 25-29 kg/m2) aged between 40 to 55 years with reports of changes in their menstrual cycle for at least 3 months.
Participants needed to have a total score of greater than 16 on the Greene Climacteric Scale (GCS), have an intact uterus and ovaries.
Early Perimenopausal Women according "The Stages of Reproductive Aging Workshop (STRAW) Classification (-2)" irregular periods without skipping menstrual cycles and more than seven days difference in length of consecutive cycles.
Subjects with serum FSH >20 U/L on 3-5 days of menstrual cycle.
Disqualifiers
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.
Subjects who had received hormonal treatment or any other herbal products in the previous 6 months.
Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
Subjects diagnosed with ovarian cysts ≥ 4 cm or any underlying pathology in pelvic ultrasonography (USG) performed during screening.
Trial design
Treatments tested in this trial
- CL25216
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov