Polycystic Ovarian Syndrome (PCOS)Phase 1NCT07459595
Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study
A Phase 1 study testing Myoinositol and Metformin in people with Polycystic Ovarian Syndrome (PCOS), run by Fatima Tariq at 1 site in Pakistan.
Trial summary
In polycystic ovary syndrome (PCOS), changes in physical appearance i.e. weight gain, hirsutism, menstrual disturbances and infertility result in reduced quality-of-life. PCOS is one of the most common endocrine disorders affecting about 4% to 8% of women of reproductive age. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- Myoinositol and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 31 Jul 2026
- Phase
- Phase 1
- 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Married or unmarried
- Diagnosed with PCOS (females presenting with compliant of irregular cycle for >3 months, with hirsutism, acne, presence of polycystic ovaries detected on ultrasound ).
Who cannot join
- Females already taken or taking PCOS treatment (on medical record)
- Females already enrolled in another trial program
- Females already taking trial drugs
- Females with chronic diabetes (BSR>200 mg/dl), hypertension (BP≥140/90mmHg)
- Females with PCOS along with gestational sac (on ultrasound)
- Females allergic to any content of trial drugs (on history)
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
CMH Gujranwala
Chak One Hundred Seventy-five Nine Left, Punjab Province, 52230
Dr Syeda Uzma, MBBS, FCPS, +92348914083, syedshezihussain78@gmail.com
About this study
In polycystic ovary syndrome (PCOS), changes in physical appearance i.e. weight gain, hirsutism, menstrual disturbances and infertility result in reduced quality-of-life. PCOS is one of the most common endocrine disorders affecting about 4% to 8% of women of reproductive age. Diagnosis is primarily clinical with Rotterdam criteria being the most commonly followed criteria, which require the presence of two out of the three criteria including oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound.
The objective of this study is to compare the outcome of Metformin versus Myo-inositol in the management of polycystic ovarian disease.
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Being tested
- Myoinositol, Metformin
- Keywords
- Metformin, Myo-inositol, Polycystic Ovarian Syndrome (PCOS)
- 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.
MyoinositolDrug
In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months.
MetforminDrug
In group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months | Experimental | Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral myoinositol 1g twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma Receives: Drug: Myoinositol |
| In group B, females will be prescribed oral metformin 850 mg twice daily for 3 months | Active comparator | Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LH/FSH ratio
It will be assessed in terms of ratio between LH and FSH after 3 months of treatment.
Measured: 3 Months
Regular cycles
It will be labeled if number of days from the start (day 1) of one period until the start (day 1) of the next period are almost equal for at least 3 months
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Tariq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatima Tariq, Combined Military Hospital Gujranwala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459595
- Sponsor's protocol ID
- 23
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study
- ClinicalTrials.gov ID
- NCT07459595
- Acronym / sponsor ID
- 23
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- Metformin, Myo-inositol, Polycystic Ovarian Syndrome (PCOS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fatima TariqUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 10 Mar 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.
In polycystic ovary syndrome (PCOS), changes in physical appearance i.e. weight gain, hirsutism, menstrual disturbances and infertility result in reduced quality-of-life. PCOS is one of the most common endocrine disorders affecting about 4% to 8% of women of reproductive age. Diagnosis is primarily clinical with Rotterdam criteria being the most commonly followed criteria, which require the presence of two out of the three criteria including oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound.
The objective of this study is to compare the outcome of Metformin versus Myo-inositol in the management of polycystic ovarian disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months | Experimental | Drug: MyoinositolInformed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral myoinositol 1g twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma |
| In group B, females will be prescribed oral metformin 850 mg twice daily for 3 months | Active comparator | Drug: MetforminInformed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Married or unmarried
- Diagnosed with PCOS (females presenting with compliant of irregular cycle for >3 months, with hirsutism, acne, presence of polycystic ovaries detected on ultrasound ).
Key exclusion criteria (6 listed)
- Females already taken or taking PCOS treatment (on medical record)
- Females already enrolled in another trial program
- Females already taking trial drugs
- Females with chronic diabetes (BSR>200 mg/dl), hypertension (BP≥140/90mmHg)
- Females with PCOS along with gestational sac (on ultrasound)
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 |
|---|---|---|
| MyoinositolIn group A, females will be prescribed oral myoinositol 1g twice daily for 3 months. | Drug | In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months |
| MetforminIn group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months. | Drug | In group B, females will be prescribed oral metformin 850 mg twice daily for 3 months |
Primary outcome
LH/FSH ratio
Time frame: 3 Months
It will be assessed in terms of ratio between LH and FSH after 3 months of treatment.
Regular cycles
Time frame: 3 Months
It will be labeled if number of days from the start (day 1) of one period until the start (day 1) of the next period are almost equal for at least 3 months
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 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Myoinositol and Metformin in people with Polycystic Ovarian Syndrome (PCOS), run by Fatima Tariq 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 2 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: opening soon, as of the sponsor's last update on 10 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dr Fatima Tariq, MBBS (+92315491846, ftmtariq@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LH/FSH ratio (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.