Health Condition 1: E280- Estrogen excess
Conditions
Interventions
None listed
Sponsors
Waleria Healthtech Pvt. Ltd., Hyderabad
Eligibility
Inclusion criteria
Inclusion criteria: Healthy women, 38 to 60 years of age who are experiencing at least two premenopausal / peri-menopausal symptoms like hot flushes, night sweats, sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual desire, joint pains or stiffness function, or any other associated symptoms and women that are pre/peri-menopausal (having irregular (longer, shorter, heavier or lighter) menstrual cycles in last 12 months or last menstruation occurred at least 3 months but no longer than 12 months ago) Sexually Active subjects reporting at least one bothersome sexual symptom Subjects with BMI between 18 and 40 kg/m at the time of screening. Subjects willing to refrain from taking any medications or preparations for addressing menopausal symptoms, such as stress or anxiety or mood or sleep, or irregular periods etc. (herbal, dietary supplements, homeopathic preparations, etc.) during the study. Subjects who are willing and able to comply with all study-related procedures, including scheduled visits, completion of assessments and questionnaires, daily intake of the investigational product, maintenance of symptom diaries (e.g., hot flash diary), and participation in follow-up evaluations In case of illiterate subjects, legally authorized/acceptable representative can provide written informed consent
Exclusion criteria
Exclusion criteria: Subjects who are having hypersensitivity or history of allergy to the study product. Subjects with sleep disturbances and/or are taking sleep aid medication. Subject with a previous history, presence or suspicion of estrogen dependent neoplasia, neoplastic disease or treatment for any neoplastic disease within the previous 2 years. Subjects who had or who have a history of hysterectomy, oophorectomy, salpingectomy or total hysterectomy Subjects with malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection are considered risky and may require special attention in clinical trials. Subject who have active or a recent history (in the last 6 months) of thromboembolic disease. Subject who had a history of cerebrovascular accident, stroke or transient ischemia. Subject who had or who have a psychiatric major depressive disorder, bipolar disorder, psychotic disorder or generalized anxiety disorder requiring therapy. Participants with a history of alcohol, tobacco dependence, or any substance abuse. Subject with a history of using estrogen or progestin-containing products in the past 12 months or hormonal therapy for peri-menopausal symptoms. Subject who are pregnant or trying to conceive actively or lactating women. Subjects with uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening with very low or very high BMI Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroid conditions) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator. Subjects who had participated in other clinical trials during the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of the Menopause Symptoms Severity Inventory (MSSI-38)Timepoint: Baseline, day 14, day 28, day 56 and day 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the individual score and further peri-menopausal symptoms using the MSSI-38 (Menopause Symptoms Severity Inventory) scale. 2. Change in the Mood Score. 3. Change in the Stress Score. 4. Change in the Sleep Score. 5. Change in the Menopause-Specific Quality of Life Score using the Menopause-Specific Quality of life (MENQOL) Questionnaire. 6. Satisfaction with treatment captured using Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ). 7. To assess the hormonal balance in the subjects: The following hormones will be tested to assess the balance (Estradiol (E2), progesterone, FSH (follicle stimulating hormone), LH (luteinizing hormone), and testosterone)Timepoint: Baseline, day 14, day 28, day 56 and day 84 | — |
Countries
India
Contacts
Public ContactDR S MADHUCHANDER
Jeevak Hospital - Multispecialty
Outcome results
None listed