Trial · NCT07603505
Effect of NAE on Polycystic Ovarian Syndrome (PCOS)
NCT07603505, Phase 1, Completed, Jinnah Sindh Medical University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Effect of NAE on Polycystic Ovarian Syndrome (PCOS). Trials, record NCT07603505. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07603505
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of NAE on Polycystic Ovarian Syndrome (PCOS)
- NCT number
- NCT07603505
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 116 participants, actual
- Lead sponsor
- Jinnah Sindh Medical University
- Conditions
- Polycystic Ovarian Syndrome (PCOS), Infertility, Metabolic Disorders
- Interventions
- Herbal Formulation, Metformin XR, Metformin 750 mg and herbal formulation 500 mg
- First posted
- 2026-05-22
- Last updated
- 2026-06-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Menstrual Cycle Normalization After 4 Months of Treatment | Baseline to 4 months | Regular ovulatory cycles lasting from 21 to 35 days achieved after finishing 4 months of treatment. Cycle regularity is recorded through menstrual diaries maintained by participants and validated by transvaginal ultrasound, where ovulation is recognized by the presence of a dominant follicle (≥18 mm) that later either collapses or vanishes, with or without free fluid present in the pouch of Douglas. |
| Secondary | Body Weight Changes | Baseline and 4 months | Change in body weight measured using a calibrated weighing scale. Unit: kg |
| Secondary | Serum Follicle-Stimulating Hormone (FSH) Levels | Baseline and 4 months | Change in serum FSH levels assessed by standard laboratory assays, reported in mIU/mL. Reference ranges: Follicular phase 3.5-12.5, Ovulatory phase 4.7-21.5, Luteal phase 1.7-7.7 |
| Secondary | Serum Luteinizing Hormone (LH) Levels | Baseline and 4 months | Change in serum LH levels assessed using standard laboratory assays, expressed in mIU/mL. Reference ranges are 1.9-9.2 during the follicular phase, 6.1-49.1 during ovulation, and 1.3-10.8 in the luteal phase |
| Secondary | Serum Testosterone Levels | Baseline and 4 months | Change in serum testosterone levels determined using standard laboratory assays, expressed in ng/mL. Normal reference range for individuals aged 18-49 years is 0.084-0.481 ng/mL. |
| Secondary | Glycated Hemoglobin (HbA1c) Level | Baseline and 4 months | Change in HbA1c (%) measured using standardized laboratory methods. Reference ranges: Normal \<5.6%, Prediabetes 5.7-6.4%, Diabetes ≥6.5% |
| Secondary | Fasting Serum Insulin Concentration | Baseline and 4 months | Change in fasting serum insulin levels assessed using standard laboratory assays, expressed in µIU/mL. Normal reference range: 2-25 µIU/mL. |
| Secondary | HOMA-IR | Baseline and 4 months | HOMA-IR will be calculated at baseline and after 4 months using the formula: HOMA-IR = \[fasting plasma glucose (mmol/L) × fasting insulin (μU/mL)\] ÷ 22.5 |
| Other | Assessment of quality of life via Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL) | Baseline and 4 months | Disease-specific questionnaire assessing 5 domains (Emotions, Body Hair, Weight, Infertility Problems, Menstrual Problems). 26 items, 7-point Likert scale (1=minimum, 7=maximum). Higher scores indicate improved quality of life. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07603505
GET https://conductscience.org/api/trials/v1/NCT07603505/registered