Clinical Research Directory

Inclusion Criteria: 1. Naturally or surgically postmenopausal female, with or without an intact uterus, aged 45-65 years, living in and around Ahmedabad city or western part of India. inclusive. Postmenopausal is defined by FDA Draft Guidance as: 1. At least 12 months natural spontaneous amenorrhea; or 2. ≥ 6 months and \< 12 months natural spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL at screening; or 3. At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. Only participants that meet one of the above criteria and have their postmenopausal status confirmed by a serum FSH level \> 40 mIU/mL are eligible for study enrollment. 2. Serum FSH level \> 40 mIU/mL; determined at screening. 3. For participants with an intact uterus, has a vaginal ultrasonography demonstrating inactive endometrial lining with endometrial thickness \< 4 mm. 4. A body weight ≤ 90 kg. Page 36 of 59 5. Seated vital signs measurements, determined at screening, as specified below (inclusive): Temperature (T) 96.5-99.4°F, Respiration Rate (RR) 12-20 breaths per minute, Pulse Rate (PR) 50-100 beats per minute, Blood Pressure (BP) 90-140 (systolic)/60-90 (diastolic) mmHg 6. Total cholesterol level ≤ 275 mg/dL. 7. Triglycerides level ≤ 350 mg/dL. 8. Good health as determined by lack of clinically significant abnormalities in the participant's medical history or health assessments performed at screening (as applicable), as determined by the Investigator (or designee), including a negative screening mammogram and/or Breast MRI and a normal clinical breast examination. 9. Participant is able to understand and comply with the study procedures, in the opinion of the Investigator, and able to give voluntary written consent for participation in the study. 10. Able and willing to comply with protocol restrictions and required study procedures and visit requirements. 11. Serum estradiol level should be clinically acceptable. 12. Serum pregnancy test must be negative. Exclusion Criteria: 1. Male Participant. 2. Participants who are premenopausal or perimenopausal, as determined by the Investigator, or pregnant, lactating or likely to become pregnant during the study. 3. History of allergy (e.g., anaphylactic reaction), hypersensitivity, or angioedema (including hereditary angioedema) to Climara Pro® or any of its components, including glues/adhesives, or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the participant or integrity of the study. 4. Presence of any current dermatological condition at the application site(s) (e.g., atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, urticaria) or conditions known to alter skin appearance or physiologic response (e.g., diabetes, porphyria) or history of allergic, sensitization or skin sensitivity that would compromise the integrity of the study data. 5. Excessive hair or other compounding factors (e.g., tattoos, scar tissue, recently shaved skin, uneven or obvious difference in skin condition or coloration, sunburn, open sores, moles, body piercings, etc.) at the application sites that, in the opinion of the Investigator, would compromise the ability of the patch to be applied. 6. History of or current evidence of hypertension, as determined by the Investigator, or has a seated systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg; determined at screening. 7. Participants with known allergic or immunological disorders (e.g., primary or acquired immunodeficiencies such as human immunodeficiency virus \[HIV\] positive or AIDS, allergic diseases such as anaphylaxis, asthma or generalized drug reaction, rheumatoid arthritis or systemic lupus erythematosus). Resolved childhood asthma or minor allergic reactions to environmental allergens or foods need not be reason for exclusion. 8. Significant history or current evidence, as determined by the Investigator, of chronic infectious disease, system disorders, organ dysfunction especially renal disorders, hepatic impairment or disease (especially prior cholestatic jaundice of pregnancy, jaundice with prior estrogen use, or hepatic hemangiomas), gallbladder disease, pancreatitis or hypertriglyceridemia, hypercalcemia, thyroid disorders (especially hypoparathyroidism), residual endometriosis post-hysterectomy, epilepsy, migraine, porphyria, or cardiovascular disorders (especially coronary heart disease). 9. Has any risk factors, as determined by the Investigator, for arterial vascular disease/arterial thrombosis (e.g., hypertension, diabetes, tobacco use, or hypercholesterolemia) or venous thromboembolism (VTE) including retinal vascular thrombosis (e.g., personal history or immediate family history of VTE, or systemic lupus erythematosus). 10. History or current evidence (i.e., active) of deep venous thrombosis (DVT) or pulmonary embolism (PE), as determined by the Investigator. 11. History or current evidence (i.e., active) of arterial thromboembolic disease (e.g., stroke, myocardial infarction, etc.), as determined by the Investigator. 12. Known or significant family history (as determined by the Investigator) of coagulation disorders (i.e., bleeding or clotting disorders) such as excessive/prolonged bleeding from cuts, bruising easily, blood clots, etc. 13. Known, suspected, significant family history (as determined by the Investigator), or history of breast cancer, bone metastases, endometrial cancer, or ovarian cancer. 14. Known or suspected (as determined by the Investigator based on participant's provided medical history) estrogen-dependent neoplasia. 15. Known or suspected (as determined by the Investigator based on participant's provided medical history) protein C, protein S, or antithrombin deficiency, or other thrombophilic disorders. 16. Undiagnosed persistent or recurring abnormal genital bleeding with unknown etiology. 17. Has a scheduled surgery of the type associated with an increased risk of thromboembolism or anticipates periods of prolonged immobilization within 6 weeks after completion of the study. 18. Contraindication to estrogen therapy or is currently taking thyroid hormone replacement therapy prior to patch application of period-I. 19. Use of medications or treatments which, in the opinion of the Investigator, could influence or adhesion/responses to the patches or could alter the inflammatory or immune responses within 3 weeks of the study start. 20. Use of pharmacologic agents or products known to significantly induce or inhibit drug-metabolizing enzymes especially inducers of CYP3A4 and inhibitors of CYP3A4 within 30 days before initial patch application of period-I. 21. Use of any of the following within the noted times before initial patch application or anticipated use during the study: * Estrogen pellet therapy or progestin injectable drug therapy within 6 months before initial patch application of period-I. * Progestin implants and estrogen alone injectable drug therapy within 3 months before initial patch application of period-I. * Oral estrogen and/or oral or intrauterine progestin therapy within 8 weeks before initial patch application of period-I. * Transdermal estrogen alone or transdermal estrogen/progestin products within 4 weeks before initial patch application of period-I. * Vaginal hormonal products (e.g., rings, creams, gels) within 1 week before initial patch application of period-I. 22. Use of prescription or over-the-counter (OTC) antihypertensives (e.g., diuretics, ACE inhibitors, angiotensin II receptor blockers, beta-blockers), pressor agents (e.g., midodrine, vasopressin, norepinephrine, epinephrine, phenylephrine, decongestants, NSAIDs like ibuprofen and naproxen), and estrogens (other than the study drug) from the time screening to initial patch application of period-I. 23. Any vaccine (including COVID-19 vaccine) within 14 days prior to patch application of period-I. 24. Use of antihistamines or use of topical drugs at application site within 72 hours prior to patch application of period-I. 25. Use of any cosmetics, moisturizers, powders, and sunscreen or other topical products (e.g., make-up, oil, lotion, creams sprays, powders, etc.) at the patch application sites within 24 hours prior to patch application of period-I. 26. Use of tobacco- or nicotine-containing products within 30 days before initial patch application of period-I. 27. Previous participation in this study. 28. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. 29. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 7 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to patch application of period I. 30. History or presence of seizure or psychiatric disorders 31. A history of difficulty in donating blood. 32. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first patch application of study medication or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first patch application of study medication\*\*. \*\* If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of investigational medicinal product received. Note: If a participant had participated in a study in which the total blood loss was ≤ 200 mL, the participant may be dosed 60 days after the last sample of the previous study. 33. Consumption of grapefruit or grapefruit products within 72 hours prior to patch application of period-I. 34. History or presence of smoking. 35. An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to patch application period-I. In any such case participant selection will be at the discretion of the Principal Investigator.