Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age16-45
SponsorFatima Tariq

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 ).

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Myoinositol

    Drug

    In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months.

  • Metformin

    Drug

    In group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: In group A, females will be prescribed oral myoinositol 1g twice daily for 3 monthsExperimental treatment 1 intervention
Group B: In group B, females will be prescribed oral metformin 850 mg twice daily for 3 monthsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

LH/FSH ratio

It will be assessed in terms of ratio between LH and FSH after 3 months of treatment.

Time frame
3 Months
2

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

Time frame
3 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Fatima Tariq

Lead sponsor

Combined Military Hospital Gujranwala

Sponsor institution

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