ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 7 for:    "Acanthosis nigricans"

Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02562664
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Brief Summary:
Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically, PCOS can identify during the early adolescence. Insulin resistance is a common finding in the obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition of its more common connection to obesity and insulin resistance allows for diagnosis of related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular randomized, double-blind, placebo-controlled trial . The first pharmacological approach to induction of ovulation in women with PCOS is clomiphene citrate

Condition or disease Intervention/treatment Phase
Reproductive Endocrinology Polycystic Ovarian Syndrome Drug: CC Drug: Placebo tablets Drug: Metformin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Insulin Sensitizing Agent (Metformin) Improves Clinical Pregnancy Rate and Insulin Parameters in Polycystic Ovarian Syndrome Patients With Acanthosis Nigricans
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CC with placebo
100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with placebo tablets taken twice daily continuously for three cycles.
Drug: CC
100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle

Drug: Placebo tablets
Placebo tablets taken twice daily continuously for three cycles.

Active Comparator: CC plus Metformin
received t100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with plus Metformin 500 mg twice daily continuously for three cycles.
Drug: CC
100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle

Drug: Metformin
wMetformin (Cidophage , Amon , Egypt) 500 mg twice daily continuously for three cycles.




Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Fasting glucose (mg/dl) [ Time Frame: 6 months ]
  2. Fasting insulin (mg/dl) [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with PCOS fulfilled at least 2 out of the three criteria of Rotterdam consensus 2003

Exclusion Criteria:

  • liver disease
  • heart or respiratory failure
  • alcohol abuse
  • kidney disease

Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02562664     History of Changes
Other Study ID Numbers: MPCOS
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: January 2014

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Clomiphene
Enclomiphene
Zuclomiphene
Hypoglycemic Agents
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators