Health Condition 1: N915- Oligomenorrhea, unspecified
Conditions
Interventions
None listed
Sponsors
Gynoveda Femtech Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female (married and unmarried) patients diagnosed with delayed periods (35 to 90 days) since 2 cycles 2. Female with natural periods without OC or hormonal pills 3. Subjects with serum AMH 1 to 4 ng per ml 4. Subjects with normal Serum FSH level 5. Subjects willing to provide written informed consent and ready to comply with the study protocol. Note: Subjects with Intramural and subserosal fibroids less than 2 cm and ovarian cysts less than 2 cm in size will be included
Exclusion criteria
Exclusion criteria: 1. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids greater than 2 cm, endometriosis, chocolate cysts, cervical erosion and PCOD (as diagnosed by USG). 2. Subjects with heavy and extended (10 days) bleeding 3. Subjects with submucosal fibroids 4. Subjects having hyperprolactinemia. 5. Subjects having known systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, hirsutism, Addison disease and or Cushing disease. 6. Subjects with known HIV, cancer, hepatitis B and C. 7. Known cases of autoimmune and chronic debilitating disease 8. Subjects on anti-depressant medications 9. Pregnant and lactating women. 10. Use of corticosteroids or hormones or hormonal drugs within last 1 month from screening visit. 11. Use of any other investigational drug within 1 month prior to screening visit. 12. Known hypersensitivity to ingredients used in study drug. 13. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects achieving regular frequency of menstrual cycleTimepoint: Baseline visit, Day 30, Day 60, Day 90 and Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in number of bleeding days, amount of menstrual bleeding 2. Number of subjects achieving ovulation during the study period 3. Change in symptoms associated with delayed periods 4. Change in weight and BMI 5. Change in skin glow 6. Assessment of spontaneous pregnancy 7. Global assessment for overall change by subject and investigator 8. Tolerability of study medications as assessed by participants and investigator 9. Safety evaluation by assessing adverse events, clinical symptoms, signs, vitals and laboratory tests Timepoint: Baseline visit, Day 30, Day 60, Day 90 and Day 120 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed