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Tests treatment safety and results for Vasomotor Symptoms
Official title Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause
ClinicalTrials.gov ID: NCT07112651
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- people with serum FSH \>20 U/L on 3-5 days of menstrual cycle.
- people with normal pelvic TVS and breast mammogram.
You likely can't join if
- History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on...
- people who had received hormonal treatment or any other herbal products in the previous 6 months.
- people underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- people diagnosed with ovarian cysts ≥ 4 cm or any underlying pathology in pelvic ultrasonography (USG) performed during screening.
- Chronic or acute life stressors relating to a major life change, experiencing depression and/or receiving medication for such illness or disorders...
- people having active gall bladder disease, gynaecological or breast surgery in the last 6 months.
See the full eligibility criteria
Who can join
- 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...
- people with serum FSH \>20 U/L on 3-5 days of menstrual cycle.
- people with normal pelvic TVS and breast mammogram.
- people with normal fasting blood glucose level (\<125 mg/dl).
- Subject understands the study procedures and provides signed informed consent to participate in the study.
- people with normal blood thyroid profile.
- Females of childbearing potential who are sexually active must agree to use adequate contraception and can neither be pregnant nor lactating from screening throughout the duration of the study.
- Clinical screening including vital signs, electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or...
What rules you out
- 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.
- people who had received hormonal treatment or any other herbal products in the previous 6 months.
- people underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- people diagnosed with ovarian cysts ≥ 4 cm or any underlying pathology in pelvic ultrasonography (USG) performed during screening.
- Chronic or acute life stressors relating to a major life change, experiencing depression and/or receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone...
- people having active gall bladder disease, gynaecological or breast surgery in the last 6 months.
- History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
- people with abnormal ECG.
- Pregnant and breast feeding female.
- History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
- Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication.
- Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids, and morphine).
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
- Participated in a clinical study with an investigational drug or biologic within the last 30 days.
- Any condition that in opinion of the investigator, does not justify the people" participation in the study.
- people with a high blood pressure at screening (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- people with progressive systemic diseases (e.g. tuberculosis, leucosis, collagenosis, multiple sclerosis, AIDS, HIV infections, Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or other auto-immune...
- Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies...
- High alcohol intake (\>2 standard drinks per day), smokers (\>5 cigarettes per day).
The study team makes the final eligibility decision.
Where it's taking place
- Vijayawada, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vijayawada, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.