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Trial record 60 of 107 for:    "21-hydroxylase deficiency"

Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism (mprmih)

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ClinicalTrials.gov Identifier: NCT03757923
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Jahan Ara Ainuddin, Dow University of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Menstrual Irregularities Hyperandrogenism Drug: TAB METFORMIN Drug: TAB PIOGLITAZONE Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trail
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : December 17, 2018
Estimated Study Completion Date : January 2019


Arm Intervention/treatment
Experimental: metformin
TAB METFORMIN 500mg TDS
Drug: TAB METFORMIN
INSULIN SENSITIZING AGENTS

Experimental: pioglitazone
TAB PIOGLITAZONE 30 mg OD
Drug: TAB PIOGLITAZONE
INSULIN SENSITIZING AGENT




Primary Outcome Measures :
  1. HIRSUTISM [ Time Frame: 3 months ]
    Hirsutism will be assessed by ferryman gallaway scoring (numerical/quantitative)

  2. POLYCYSTIC OVARIES [ Time Frame: 3 months ]
    assessment on ultrasound (qualitative-present/not present)

  3. MENSTRUAL IRREGULARITIES [ Time Frame: 3 months ]
    assessment on history(qualitative-present/not present)

  4. BMI [ Time Frame: 3 months ]
    weight and height will be combined to report BMI in kg/m2


Secondary Outcome Measures :
  1. SERUM FASTING INSULIN [ Time Frame: 3 months ]
    unit of measure: uIU/ml

  2. FASTING BLOOD SUGAR [ Time Frame: 3 months ]
    unit of measure:mg/dl

  3. FREE TESTOSTERONE [ Time Frame: 3 months ]
    unit of measure :nmol/l

  4. FREE ANDROGEN INDEX [ Time Frame: 3 months ]
    numerical



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757923


Contacts
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Contact: Jahan A Ainuddin 03012530961 jahanaraainuddin@yahoo.com

Locations
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Pakistan
Dow University Hospital OJHA Recruiting
Karachi, Sindh, Pakistan, 75270
Sponsors and Collaborators
Dow University of Health Sciences
Investigators
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Study Director: Bader F Zuberi, FCPS Dow University of Health Sciences

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Responsible Party: Jahan Ara Ainuddin, Professor, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT03757923     History of Changes
Other Study ID Numbers: DowUHS3
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jahan Ara Ainuddin, Dow University of Health Sciences:
PCO
Metformin
Additional relevant MeSH terms:
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Adrenogenital Syndrome
Hyperandrogenism
Menstruation Disturbances
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
Pathologic Processes
Metformin
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs