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Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03757923
Acronym
mprmih
Enrollment
110
Registered
2018-11-29
Start date
2018-06-18
Completion date
2019-01-31
Last updated
2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperandrogenism, Menstrual Irregularities

Keywords

PCO, Metformin

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.

Interventions

DRUGTAB METFORMIN

INSULIN SENSITIZING AGENTS

DRUGTAB PIOGLITAZONE

INSULIN SENSITIZING AGENT

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomized controlled trail

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
BMI3 monthsweight and height will be combined to report BMI in kg/m2
HIRSUTISM3 monthsHirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)
POLYCYSTIC OVARIES3 monthsassessment on ultrasound (qualitative-present/not present)
MENSTRUAL IRREGULARITIES3 monthsassessment on history(qualitative-present/not present)

Secondary

MeasureTime frameDescription
SERUM FASTING INSULIN3 monthsunit of measure: uIU/ml
FASTING BLOOD SUGAR3 monthsunit of measure:mg/dl
FREE TESTOSTERONE3 monthsunit of measure :nmol/l
FREE ANDROGEN INDEX3 monthsnumerical

Countries

Pakistan

Contacts

Primary ContactJahan A Ainuddin
jahanaraainuddin@yahoo.com03012530961

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026