Authors
»
Ixoreal Biomed Private Limited -More
Category
»
Primary study
Registry of Trials»Clinical Trials Registry - India
Year
»
2026
INTERVENTION: CONDITION: PRIMARY OUTCOME: Mean change in scores for Female Sexual Function Index (FSFI) from baseline.Timepoint: Baseline, Week 4, Week 8, Week 12 SECONDARY OUTCOME: Change in Patient‐Reported Outcomes Measurement Information System (PROMIS) scores from baseline to week 12.Timepoint: Baseline, Week 4, Week 8, Week 12 Mean Change in Bedtime cortisol levels from baseline.Timepoint: Baseline and Week 12 Mean change in Global measure of sexual satisfaction (GMSEX) scores from baseline to week 12Timepoint: Baseline, Week 4, Week 8, Week 12 Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline.Timepoint: Baseline, Week 12 Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baselineTimepoint: Baseline, Week 12 Mean Change in Salivary Cortisol Awakening response (CAR) from baseline to Week 12Timepoint: Baseline and Week 12 Mean change in scores for Female Sexual Distress Scale (FSDS) from baseline to week 12.Timepoint: Baseline, Week 4, Week 8, Week 12 Mean change in scores for Perceived Stress Scale (PSS) from baseline to week 12.Timepoint: Baseline, Week 4, Week 8, Week 12 Mean change in Thyroid (T3, T4, TSH) parameters from baseline.Timepoint: Baseline, Week 12 Number and proportion of Treatment‐Emergent Adverse Events (TEAEs) over 12 weeksTimepoint: Baseline, Week 4, Week 8, Week 12 Number and proportion of Treatment‐Emergent Serious Adverse Events (TESAE) over 12 weeks.Timepoint: Baseline, Week 4, Week 8, Week 12 INCLUSION CRITERIA: 1. Women between 20 to 50 years of age. 2. Sexually active, attempting sexual activity, or experiencing concerns related to sexual desire or function, with a partner and have a total FSFI score of smaller than or equal to 26.55. 3. Have a PSS‐10 score of greater than or equal to 14. 4. Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.). 5. Participants who are reliable, honest, compliant, and agree to co‐operate with all trial evaluations as well as to be able to perform them as per investigator s opinion. 6. Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff. 7. Able to read and write in English or any other ve
Epistemonikos ID: 1ca3f2de7a48095da2ddff524afc7bcec1ead1a2
First added on: Aug 08, 2026