Clinical trial NCT03757923: Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
Official title: Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Menstrual Irregularities
Hyperandrogenism
Keywords: PCO
Metformin
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trail
Primary purpose: TREATMENT

Brief summary: To compare metformin with pioglitazone in improving menstrual irregularities and hyperandrogenism in women with PCOS so that an alternate and better treatment option will be available for hyperinsulinemia in pcos patients.

Detailed description: This study will be a prospective, randomized, open label, multicentre study. It will be carried out in outpatients department of Obstetrics and gynecology, at the Dow university of Hospital and mamji hospital Karachi.

The study period will be of 6 months. Polycystic ovarian syndrome PCOS constitute most common endocrinopathy present in 4-7% women of reproductive age. Rotterdam criteria, diagnosis of PCOS require two of the three features: oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries by u/s and the absence of other endocrine conditions such as hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, or hyperprolactinemia.

Insulin resistance and hyperinsulinemia may play a key role in pathogenesis of this syndrome by deregulating LH secretion at central level and increased stimulation of cytochrome p450 in ovary, hyperinsulinemia also decreases the circulating concentration of SHBG and contribute to greater concentration of free androgens in blood, cut off of insulin level for insulin resistance in Pakistani population is 9.25U/ml. On basis of evidence, Insulin sensitizing agents has been recently proposed as a useful treatment option in women with pcos, which by reducing insulin resistance and hyperinsulinemia, reduce the insulin driven ovarian and adrenal hyperandrogenism usually restoring normal LH and FSH secretion and ovulatory cycles.

Eligibility criteria: Inclusion Criteria:

1. women of age 18-40 with primary or secondary infertility.
2. Polycystic ovarian syndrome daignosed using rotterdam criteria.
3. Not taken any medication before for PCOS.

Exclusion Criteria:

1. Women having type 1 or type 2 diabetes mellitus.
2. Abnormal kidney or liver function.
3. Hypertension or heart disease.
4. Gonadotrophin induction or ovarian drilling before will not be included in this study.

Primary outcomes:
measure: HIRSUTISM
timeFrame: 3 months
measure: POLYCYSTIC OVARIES
timeFrame: 3 months
measure: MENSTRUAL IRREGULARITIES
timeFrame: 3 months
measure: BMI
timeFrame: 3 months
Secondary outcomes:
measure: SERUM FASTING INSULIN
timeFrame: 3 months
measure: FASTING BLOOD SUGAR
timeFrame: 3 months
measure: FREE TESTOSTERONE
timeFrame: 3 months
measure: FREE ANDROGEN INDEX
timeFrame: 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University Hospital OJHA
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Bader F Zuberi, FCPS
role: STUDY_DIRECTOR
References: