Polycystic Ovary SyndromeNCT07747909
Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial
A study testing Orlistat and Standard Lifestyle Advice in people with Polycystic Ovary Syndrome, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
This randomized controlled clinical trial aims to evaluate the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Orlistat and Standard Lifestyle Advice
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged 18-45 years.
- Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam Criteria (presence of any two of the following):
- Oligomenorrhea or amenorrhea.
- Clinical or biochemical hyperandrogenism.
- Polycystic ovaries on ultrasonography.
- Body mass index (BMI) between 18.5 and 35 kg/m² (Asian criteria).
Who cannot join
- Current or recent use of oral contraceptives, ovulation induction medications, anti-obesity medications, cholesterol-lowering medications, or other therapies/supplements known to affect insulin physiology or androgen metabolism (e.g., inositols, curcumin, lipoic acid, cinnamon, gymnemic, or other botanical extracts).
- Women undergoing in vitro fertilization (IVF) treatment.
- Known congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus.
- Presence of severe renal or liver disease.
- Menopausal, pregnant, or breastfeeding women.
- Anti-Müllerian Hormone (AMH) < 0.7 ng/mL.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Ayub Teaching Hospital
Abbottābād, Khyber Pakhtunkhwa
Dr. Ruqqiya Sultana, MBBS, +92 314 5014992, ruqqia_sultana@yahoo.com
Dr Syed Muhammad Shabbir Ali Naqvi, PhD*, +923460113227, coordinator.ctu@kmu.edu.pk
About this study
This randomized controlled clinical trial aims to evaluate the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle advice or placebo plus standard lifestyle advice for three months. The study will assess the effect of orlistat on hormonal parameters, glucose metabolism, lipid profile, liver function, anthropometric measures, non-alcoholic fatty liver disease, and quality of life to determine its effectiveness as an adjunctive treatment for women with PCOS.
Read the detailed description
Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders affecting women of reproductive age and is frequently associated with obesity, insulin resistance, dyslipidemia, and hormonal imbalance. Lifestyle modification remains the cornerstone of management; however, additional therapeutic options are needed to improve metabolic and reproductive outcomes. Orlistat, a gastrointestinal lipase inhibitor, promotes weight reduction by decreasing dietary fat absorption and has demonstrated potential benefits in improving insulin resistance and lipid metabolism.
This study is a single-center, randomized controlled clinical trial to be conducted at Ayub Teaching Hospital, Abbottabad. A total of 120 women aged 18-45 years with PCOS diagnosed according to the Rotterdam criteria will be enrolled and randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive orlistat capsules twice daily in addition to standard lifestyle advice, while participants in the control group will receive placebo together with the same lifestyle recommendations, including a healthy diet and regular physical activity. The intervention period will last three months.
Participants will undergo baseline assessment, telephone follow-up visits at one and two months to monitor treatment adherence, and a final in-person assessment after three months. The primary outcome is improvement in at least one abnormality defined by the Rotterdam diagnostic criteria. Secondary outcomes include changes in sex hormone profile (LH, FSH, LH/FSH ratio, AMH, and free testosterone), fasting glucose and insulin parameters, HbA1c, lipid profile, liver function tests, lipid accumulation product, hepatic steatosis index, ultrasound grading of non-alcoholic fatty liver disease, anthropometric measures, and PCOS-related quality of life. The findings of this study will provide evidence regarding the effectiveness of orlistat as an adjunct to lifestyle modification for improving the metabolic and hormonal manifestations of PCOS in women.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Orlistat, Placebo, Standard Lifestyle Advice
- Keywords
- PCOS, Orlistat, Lifestyle Intervention, Quality of Life
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrlistatDrug
Also called Oral Orlistat capsules
Oral Orlistat capsules administered twice daily between lunch and dinner for 3 months as an adjunct to the recommended care plan for women with polycystic ovary syndrome (PCOS). Participants will also receive standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling.
PlaceboDrug
Matching placebo capsules administered twice daily for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling, for women with polycystic ovary syndrome (PCOS).
Standard Lifestyle AdviceBehavioural
Also called Lifestyle Modification
Participants will receive standardized lifestyle advice, including maintaining a healthy diet, engaging in regular physical activity, and performing at least 30 minutes of walking or cycling daily throughout the 3-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Orlistat + Standard Lifestyle Advice | Experimental | Participants will receive oral Orlistat capsules twice daily between lunch and dinner for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking or cycling for at least 30 minutes daily, and other lifestyle modifications. Receives: Drug: Orlistat; Behavioral: Standard Lifestyle Advice |
| Placebo + Standard Lifestyle Advice | Placebo comparator | Participants will receive matching placebo capsules twice daily for 3 months together with the same standard lifestyle advice, including a healthy diet, regular physical activity, walking or cycling for at least 30 minutes daily, and other lifestyle modifications Receives: Drug: Placebo; Behavioral: Standard Lifestyle Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polycystic Ovary Syndrome (PCOS) Features
Improvement in at least one baseline abnormality according to the Rotterdam Criteria, including ovulatory dysfunction, hyperandrogenism, or polycystic ovarian morphology on ultrasonography.
Measured: Baseline and 3 months
Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) Ratio
Change in serum LH/FSH ratio measured by laboratory assay. Higher values indicate greater hormonal imbalance.
Measured: Baseline and 3 months
Anti-Müllerian Hormone (AMH)
Change in serum Anti-Müllerian Hormone concentration (ng/mL) measured by laboratory assay.
Measured: Baseline and 3 months
Follicle Stimulating Hormone (FSH)
Change in serum FSH concentration (IU/L) measured by laboratory assay
Measured: Baseline and 3 months
Luteinizing Hormone (LH)
Change in serum LH concentration (IU/L) measured by laboratory assay.
Measured: Baseline and 3 months
Free Testosterone
Change in serum free testosterone concentration measured by laboratory assay.
Measured: Baseline and 3 months
Fasting Blood Glucose
Change in fasting blood glucose concentration (mg/dL) measured by laboratory assay.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Jan 2026
- Primary completion10 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups using simple randomization. The intervention group will receive orlistat in addition to standard lifestyle advice, while the control group will receive placebo plus the same standard lifestyle advice for three months. Participants will remain in their assigned group throughout the study.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Dr Ruqqiya Sultana, MBBS, Principal investigator, Khyber Medical Univeristy PeshawarDr Noman Arif, PhD, Principal investigator, Khyber Medical Univeristy Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747909
- Sponsor's protocol ID
- KMU/DIR/CTU/2026/09
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, baseline and outcome data, will be made available to qualified researchers upon reasonable request after publication of the primary study results.
Publications
March WA, Moore VM, Willson KJ, Phillips DI, Norman RJ, Davies MJ. The prevalence of polycystic ovary syndrome in a community sample assessed under contrasting diagnostic criteria. Hum Reprod. 2010 Feb;25(2):544-51. doi: 10.1093/humrep/dep399. Epub 2009 Nov 12.
PubMed 19910321Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.
PubMed 16157765Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
PubMed 19805654Teede HJ, Misso ML, Deeks AA, Moran LJ, Stuckey BG, Wong JL, Norman RJ, Costello MF; Guideline Development Groups. Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline. Med J Aust. 2011 Sep 19;195(6):S65-112. doi: 10.5694/mja11.10915. No abstract available.
PubMed 21929505Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.
PubMed 23764390
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07747909
- Acronym / sponsor ID
- KMU/DIR/CTU/2026/09
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Orlistat, Lifestyle Intervention, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical trial aims to evaluate the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle advice or placebo plus standard lifestyle advice for three months. The study will assess the effect of orlistat on hormonal parameters, glucose metabolism, lipid profile, liver function, anthropometric measures, non-alcoholic fatty liver disease, and quality of life to determine its effectiveness as an adjunctive treatment for women with PCOS.
Detailed description
Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders affecting women of reproductive age and is frequently associated with obesity, insulin resistance, dyslipidemia, and hormonal imbalance. Lifestyle modification remains the cornerstone of management; however, additional therapeutic options are needed to improve metabolic and reproductive outcomes. Orlistat, a gastrointestinal lipase inhibitor, promotes weight reduction by decreasing dietary fat absorption and has demonstrated potential benefits in improving insulin resistance and lipid metabolism.
This study is a single-center, randomized controlled clinical trial to be conducted at Ayub Teaching Hospital, Abbottabad. A total of 120 women aged 18-45 years with PCOS diagnosed according to the Rotterdam criteria will be enrolled and randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive orlistat capsules twice daily in addition to standard lifestyle advice, while participants in the control group will receive placebo together with the same lifestyle recommendations, including a healthy diet and regular physical activity. The intervention period will last three months.
Participants will undergo baseline assessment, telephone follow-up visits at one and two months to monitor treatment adherence, and a final in-person assessment after three months. The primary outcome is improvement in at least one abnormality defined by the Rotterdam diagnostic criteria. Secondary outcomes include changes in sex hormone profile (LH, FSH, LH/FSH ratio, AMH, and free testosterone), fasting glucose and insulin parameters, HbA1c, lipid profile, liver function tests, lipid accumulation product, hepatic steatosis index, ultrasound grading of non-alcoholic fatty liver disease, anthropometric measures, and PCOS-related quality of life. The findings of this study will provide evidence regarding the effectiveness of orlistat as an adjunct to lifestyle modification for improving the metabolic and hormonal manifestations of PCOS in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups using simple randomization. The intervention group will receive orlistat in addition to standard lifestyle advice, while the control group will receive placebo plus the same standard lifestyle advice for three months. Participants will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Orlistat + Standard Lifestyle Advice | Experimental | Drug: Orlistat, Behavioral: Standard Lifestyle AdviceParticipants will receive oral Orlistat capsules twice daily between lunch and dinner for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking or cycling for at least 30 minutes daily, and other lifestyle modifications. |
| Placebo + Standard Lifestyle Advice | Placebo comparator | Drug: Placebo, Behavioral: Standard Lifestyle AdviceParticipants will receive matching placebo capsules twice daily for 3 months together with the same standard lifestyle advice, including a healthy diet, regular physical activity, walking or cycling for at least 30 minutes daily, and other lifestyle modifications |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females aged 18-45 years.
- Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam Criteria (presence of any two of the following):
- Oligomenorrhea or amenorrhea.
- Clinical or biochemical hyperandrogenism.
- Polycystic ovaries on ultrasonography.
Key exclusion criteria (6 listed)
- Current or recent use of oral contraceptives, ovulation induction medications, anti-obesity medications, cholesterol-lowering medications, or other therapies/supplements known to affect insulin physiology or androgen metabolism (e.g., inositols, curcumin, lipoic acid, cinnamon, gymnemic, or other botanical extracts).
- Women undergoing in vitro fertilization (IVF) treatment.
- Known congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus.
- Presence of severe renal or liver disease.
- Menopausal, pregnant, or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrlistatAlso: Oral Orlistat capsulesOral Orlistat capsules administered twice daily between lunch and dinner for 3 months as an adjunct to the recommended care plan for women with polycystic ovary syndrome (PCOS). Participants will also receive standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling. | Drug | Orlistat + Standard Lifestyle Advice |
| PlaceboMatching placebo capsules administered twice daily for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling, for women with polycystic ovary syndrome (PCOS). | Drug | Placebo + Standard Lifestyle Advice |
| Standard Lifestyle AdviceAlso: Lifestyle ModificationParticipants will receive standardized lifestyle advice, including maintaining a healthy diet, engaging in regular physical activity, and performing at least 30 minutes of walking or cycling daily throughout the 3-month study period. | Behavioural | Orlistat + Standard Lifestyle Advice, Placebo + Standard Lifestyle Advice |
Primary outcome
Polycystic Ovary Syndrome (PCOS) Features
Time frame: Baseline and 3 months
Improvement in at least one baseline abnormality according to the Rotterdam Criteria, including ovulatory dysfunction, hyperandrogenism, or polycystic ovarian morphology on ultrasonography.
Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) Ratio
Time frame: Baseline and 3 months
Change in serum LH/FSH ratio measured by laboratory assay. Higher values indicate greater hormonal imbalance.
Anti-Müllerian Hormone (AMH)
Time frame: Baseline and 3 months
Change in serum Anti-Müllerian Hormone concentration (ng/mL) measured by laboratory assay.
Follicle Stimulating Hormone (FSH)
Time frame: Baseline and 3 months
Change in serum FSH concentration (IU/L) measured by laboratory assay
Luteinizing Hormone (LH)
Time frame: Baseline and 3 months
Change in serum LH concentration (IU/L) measured by laboratory assay.
Free Testosterone
Time frame: Baseline and 3 months
Change in serum free testosterone concentration measured by laboratory assay.
Fasting Blood Glucose
Time frame: Baseline and 3 months
Change in fasting blood glucose concentration (mg/dL) measured by laboratory assay.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 19910321March WA, Moore VM, Willson KJ, Phillips DI, Norman RJ, Davies MJ. The prevalence of polycystic ovary syndrome in a community sample assessed under contrasting diagnostic criteria. Hum Reprod. 2010 Feb;25(2):544-51. doi: 10.1093/humrep/dep399. Epub 2009 Nov 12.
- Background: PubMed 16157765Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.
- Background: PubMed 19805654Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
- Background: PubMed 21929505Teede HJ, Misso ML, Deeks AA, Moran LJ, Stuckey BG, Wong JL, Norman RJ, Costello MF; Guideline Development Groups. Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline. Med J Aust. 2011 Sep 19;195(6):S65-112. doi: 10.5694/mja11.10915. No abstract available.
- Background: PubMed 23764390Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, baseline and outcome data, will be made available to qualified researchers upon reasonable request after publication of the primary study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof Dr Ruqqiya Sultana, MBBS principal investigator
Khyber Medical Univeristy Peshawar
Dr Noman Arif, PhD principal investigator
Khyber Medical Univeristy Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orlistat and Standard Lifestyle Advice in people with Polycystic Ovary Syndrome, run by Khyber Medical University Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof Dr Ruqqiya Sultana, MBBS (+92 314 5014992, ruqqia_sultana@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polycystic Ovary Syndrome (PCOS) Features (time frame: Baseline and 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07747909, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.