Polycystic Ovary Syndrome (PCOS)Phase 4NCT07701525
Myo-Inositol and D-Chiro-Inositol for Menstrual Irregularities and Hormone Changes in Women With Polycystic Ovarian Syndrome
A Phase 4 study testing Myo-Inositol and D-Chiro-Inositol Combination Therapy in people with Polycystic Ovary Syndrome (PCOS) and Myo-inositol, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to determine whether a combination of myo-inositol (MI) and D-chiro-inositol (DCI) with folic acid is more effective than placebo (Folic acid alone) in improving menstrual irregularities and hormone levels in women with polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Myo-inositol, D-chiro-inositol
- What is being tested?
- Myo-Inositol and D-Chiro-Inositol Combination Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- diagnosed case of PCOS, ≥ 6-months
Who cannot join
- Hyperprolactinemia, hypothyroidism, adrenal hyperplasia or Cushing's syndrome (on history \& medical record review)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Nishtar Medical University and Hospital Multan
Multan, Punjab Province, 60000
About this study
Official title: Effect of Myo-Inositol and D-Chiro-Inositol Combination Therapy on Improvement in Menstrual Irregularities and Biochemical Characteristics in Patients With Polycystic Ovarian Syndrome
The goal of this clinical trial is to determine whether a combination of myo-inositol (MI) and D-chiro-inositol (DCI) with folic acid is more effective than placebo (Folic acid alone) in improving menstrual irregularities and hormone levels in women with polycystic ovarian syndrome (PCOS).
The main questions this study aims to answer are:
Read more
- Does treatment with myo-inositol and D-chiro-inositol improve menstrual regularity in women with PCOS compared with placebo?
- Does the treatment improve biochemical characteristics, including luteinizing hormone (LH), follicle-stimulating hormone (FSH), and testosterone levels, compared with placebo?
Researchers will compare a combination of myo-inositol and D-chiro-inositol with a placebo (folic acid alone) to determine whether the combination therapy is more effective in treating PCOS-related menstrual and hormonal abnormalities.
Participants will:
- Be randomly assigned to receive either a myo-inositol and D-chiro-inositol combination tablet (40:1 ratio) or placebo twice daily for 3 months.
- Have blood samples collected before starting treatment and after 3 months to measure LH, FSH, and testosterone levels.
- Attend monthly follow-up visits during the 3-month treatment period to assess changes in menstrual regularity and monitor their progress.
The study will enroll 60 women aged 18-45 years with PCOS at the Department of Obstetrics and Gynecology, Nishtar Hospital Multan. The results may help determine whether myo-inositol and D-chiro-inositol combination therapy is an effective treatment for improving menstrual function and hormonal abnormalities in women with PCOS.
- Being tested
- Myo-Inositol and D-Chiro-Inositol Combination Therapy, placebo (folic acid)
- Keywords
- Menstrual Irregularities, Oligomenorrhea, Amenorrhea, Menorrhagia, Hyperandrogenism, Testosterone, Luteinizing Hormone, Follicle-Stimulating Hormone, PCOS
- Medical subject headings
- Polycystic Ovary Syndrome, Menstruation Disturbances, Oligomenorrhea, Amenorrhea, Menorrhagia, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-Inositol and D-Chiro-Inositol Combination TherapyDrug
Participants will receive an oral combination tablet containing myo-inositol (550 mg), D-chiro-inositol (13.8 mg) in a 40:1 ratio, and folic acid (200 µg), taken twice daily for 3 months.
placebo (folic acid)Drug
Participants will receive oral folic acid (200 µg) tablets twice daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Myo-Inositol and D-Chiro-Inositol Combination Therapy | Experimental | Participants will receive a combination tablet containing myo-inositol, D-chiro-inositol, and folic acid Receives: Drug: Myo-Inositol and D-Chiro-Inositol Combination Therapy |
| Placebo | Placebo comparator | Participants will receive folic acid tablets orally Receives: Drug: placebo (folic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Menstrual Irregularity
The proportion of participants achieving improvement in menstrual irregularity after treatment. Improvement is defined as restoration of a regular menstrual cycle with an average cycle length of 24-32 days and menstrual blood loss of 21-50 mL per cycle. Menstrual irregularity includes amenorrhea, oligomenorrhea, or menorrhagia assessed through participant menstrual history.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jun 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amna Razzaq, Nishtar Medical University
- Investigators
- Mehnaz K Professor, FCPS, Study chair, Nishtar Medical University and Hospital Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701525
- Sponsor's protocol ID
- U1111-1343-2897
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myo-Inositol and D-Chiro-Inositol Combination Therapy on Improvement in Menstrual Irregularities and Biochemical Characteristics in Patients With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT07701525
- Acronym / sponsor ID
- U1111-1343-2897
- Keywords
- Menstrual Irregularities, Oligomenorrhea, Amenorrhea, Menorrhagia, Hyperandrogenism, Testosterone, Luteinizing Hormone, Follicle-Stimulating Hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 14 Jul 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.
The goal of this clinical trial is to determine whether a combination of myo-inositol (MI) and D-chiro-inositol (DCI) with folic acid is more effective than placebo (Folic acid alone) in improving menstrual irregularities and hormone levels in women with polycystic ovarian syndrome (PCOS).
The main questions this study aims to answer are:
- Does treatment with myo-inositol and D-chiro-inositol improve menstrual regularity in women with PCOS compared with placebo?
- Does the treatment improve biochemical characteristics, including luteinizing hormone (LH), follicle-stimulating hormone (FSH), and testosterone levels, compared with placebo?
Researchers will compare a combination of myo-inositol and D-chiro-inositol with a placebo (folic acid alone) to determine whether the combination therapy is more effective in treating PCOS-related menstrual and hormonal abnormalities.
Participants will:
- Be randomly assigned to receive either a myo-inositol and D-chiro-inositol combination tablet (40:1 ratio) or placebo twice daily for 3 months.
- Have blood samples collected before starting treatment and after 3 months to measure LH, FSH, and testosterone levels.
- Attend monthly follow-up visits during the 3-month treatment period to assess changes in menstrual regularity and monitor their progress.
The study will enroll 60 women aged 18-45 years with PCOS at the Department of Obstetrics and Gynecology, Nishtar Hospital Multan. The results may help determine whether myo-inositol and D-chiro-inositol combination therapy is an effective treatment for improving menstrual function and hormonal abnormalities in women with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myo-Inositol and D-Chiro-Inositol Combination Therapy | Experimental | Drug: Myo-Inositol and D-Chiro-Inositol Combination TherapyParticipants will receive a combination tablet containing myo-inositol, D-chiro-inositol, and folic acid |
| Placebo | Placebo comparator | Drug: placebo (folic acid)Participants will receive folic acid tablets orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosed case of PCOS, ≥ 6-months
Key exclusion criteria (1 listed)
- Hyperprolactinemia, hypothyroidism, adrenal hyperplasia or Cushing's syndrome (on history \& medical record review)
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 |
|---|---|---|
| Myo-Inositol and D-Chiro-Inositol Combination TherapyParticipants will receive an oral combination tablet containing myo-inositol (550 mg), D-chiro-inositol (13.8 mg) in a 40:1 ratio, and folic acid (200 µg), taken twice daily for 3 months. | Drug | Myo-Inositol and D-Chiro-Inositol Combination Therapy |
| placebo (folic acid)Participants will receive oral folic acid (200 µg) tablets twice daily for 3 months. | Drug | Placebo |
Primary outcome
Improvement in Menstrual Irregularity
Time frame: From enrollment to the end of treatment at 3 months
The proportion of participants achieving improvement in menstrual irregularity after treatment. Improvement is defined as restoration of a regular menstrual cycle with an average cycle length of 24-32 days and menstrual blood loss of 21-50 mL per cycle. Menstrual irregularity includes amenorrhea, oligomenorrhea, or menorrhagia assessed through participant menstrual history.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome (PCOS)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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. This study is not recruiting at the moment.
Mehnaz K Professor, FCPS study chair
Nishtar Medical University and Hospital Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myo-Inositol and D-Chiro-Inositol Combination Therapy in people with Polycystic Ovary Syndrome (PCOS) and Myo-inositol, run by Nishtar Medical University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Menstrual Irregularity (time frame: From enrollment to the end of treatment at 3 months). 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 14 Jul 2026.