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Polycystic Ovary SyndromePhase 2/3NCT06140108

Empagliflozin vs Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

A Phase 2/3 study testing Empagliflozin 10 MG and MetFORMIN 500 Mg Oral Tablet in people with Polycystic Ovary Syndrome and Weight Gain, run by SINA Health Education and Welfare Trust at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

this is open labelled randomize control trial among women with PCOS. PCOS, an endocrine condition, affects 5%-15% of premenopausal women. PCOS is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. Read more about this study

Who is it for?
Ages 15 to 49 years, women only
Conditions the study is for
Polycystic Ovary Syndrome, Weight Gain, HbA1c
What is being tested?
Empagliflozin 10 MG and MetFORMIN 500 Mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 sitePakistan
Study dates
15 Dec 2023to 30 Jun 2024
Phase
Phase 2/3
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 15 to 49 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • All women participants belong to the reproductive age group, i.e., 18 to 45 years will be included in the study.
  • All those women of BMI of greater than 25 kg/m2 will be included in this study
  • Women with a diagnosis of PCOS by using two (hyperandrogenism and oligo-anovulation) out of three (oligo-anovulation, hyperandrogenism and polycystic ovaries) Rotterdam criteria 2 which confirm hyperandrogenism (acne, seborrhea, hair loss on the scalp, increased body or facial hair) on clinical judgement will be included in the study
  • Those who documented and self-reported oligomenorrhea (cycle length greater than 35 days and nine or fewer periods per year) will be included. or
  • Those who report amenorrhea (absence of menses for a period of 3 months) will be inclusion criteria of the study.
  • 6- PCO Women with or without comorbidity or Multimorbidity specifically, Hypothyroidism, Diabetes, Hypertension.
  • -

Who cannot join

  • Women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, Cushing's disease, or androgen- secreting tumors will be streaked from participating.
  • In addition to this, Pregnancy or intent to become pregnant, breastfeeding, documented use of oral hormonal contraceptives and hormone- releasing implants, clomiphene citrate or oestrogen modulators, gonadotropin-releasing hormone (GnRH) modulators and Minoxidil will be excluded.
  • History or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study
  • Women with recurrent complaint of urinary tract infection (UTI)will be excluded from the study.
  • -

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • SINA Yousuf Sb Goth

    Karachi, Sindh, 74800

Other trials in Pakistan

About this study

Official title: Comparing the Effects of Empagliflozin and Metformin on Metabolic Dysfunction in Polycystic Ovary Syndrome With or Without Comorbidity or Multimorbidity

this is open labelled randomize control trial among women with PCOS. PCOS, an endocrine condition, affects 5%-15% of premenopausal women. PCOS is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. Metformin is now an option for PCOS. The clinical reactions to metformin are limited and varied. Novel SGLT2 inhibitors treat type 2 diabetes with weight loss, insulin resistance reduction, and cardiovascular benefits. There is little evidence on SGLT2 inhibitor effectiveness in PCOS patients.

Being tested
Empagliflozin 10 MG, MetFORMIN 500 Mg Oral Tablet
Medical subject headings
Polycystic Ovary Syndrome, Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 10 MGDrug

    Also called EMPAA 10mg

    Each participant will receive empagliflozin 10mg daily for 6 months.

  • MetFORMIN 500 Mg Oral TabletDrug

    Also called Glucophage 500mg

    Each participant will receive metformin 1000mg daily for 6 months.

Study groups in NCT06140108
Study groupRoleWhat they receive
Empagliflozin 10mgExperimentalEach participant will receive empagliflozin 10mg daily for 6 months
Receives: Drug: Empagliflozin 10 MG
Metformin 500mgActive comparatorEach participant will receive metformin 1000mg daily for 6 months
Receives: Drug: MetFORMIN 500 Mg Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Irregular menstruations assessment

    Assessment of Irregular menstruation measured by menstruations lasts 2 to 7 days after three months of treatment with either empagliflozin 10mg or metformin 1000mg daily.

    Measured: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

Secondary outcomes (6)

  1. Body weight

    assessment of change in Body weight in Kg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Measured: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  2. Systolic Blood Pressure (SBP)

    assessment of change in SBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Measured: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  3. Lipid profile measured through biochemical test

    assessment of change in Blood Pressure in mg/dL after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Measured: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  4. Hb1c test

    assessment of change in Hb1c level in percentage after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Measured: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  5. fasting blood-glucose measured through biochemical test

    assessment of fasting blood-glucose in mmol/L after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Measured: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

  6. Diastolic Blood Pressure (DBP)

    assessment of change in DBP in mm/Hg after three months treatment with either empagliflozin 10mg or metformin 1000mg daily

    Measured: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start15 Dec 2023
  3. Primary completion30 May 2024
  4. Study completion30 Jun 2024

Resources

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 2/3
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06140108
Sponsor's protocol ID
00002
Status last verified
May 2025
First submitted
7 Nov 2023
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharif H, Arsalan S, Rehman N, Muzammil A, Hatif F, Wasti F, Rehman S, Mohsin N, Nasir R, Omair W. Comparative effects of empagliflozin and metformin on metabolic dysfunction in polycystic ovary syndrome, a double blinded randomized control feasibility trial. BMC Womens Health. 2025 Nov 19;25(1):565. doi: 10.1186/s12905-025-04091-6.

    PubMed 41257673

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Empagliflozin 10 MG and MetFORMIN 500 Mg Oral Tablet in people with Polycystic Ovary Syndrome and Weight Gain, run by SINA Health Education and Welfare Trust 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 7 inclusion and 5 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 May 2025. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Irregular menstruations assessment (time frame: Six months treatment with either empagliflozin 10mg or metformin 1000mg daily). 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 NCT06140108, which also lists 1 linked publication.

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 May 2025.

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