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The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C.VOSNAKIS, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01475019
First received: November 14, 2011
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

The first aim of the investigators study, was to investigate the combined effect of diet,physical exercise and orlistat, for 24 weeks, on serum Anti-Müllerian Hormone (AMH) levels in obese women with polycystic ovary syndrome (PCOS) and in obese controls.

The other aim of the investigators study, was to examine the effect of hypocaloric diet,physical exercise plus sibutramine on serum AMH levels, body composition, hormonal and metabolic parameters in overweight and obese patients with polycystic ovary syndrome (PCOS).


Condition Intervention Phase
Obesity
Polycystic Ovaries Syndrome
 Drug: Orlistat
Drug: Sibutramine
Behavioral: Diet and physical exercise
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Weight Loss With Orlistat or Sibutramine Administration , Hypocaloric Diet and Physical Exercise , on AMH Levels, in Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Anti- Mullerian hormone (AMH) levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Androgen levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Free androgen index, Testosterone, 17OH Progesterone, D4 Andostenedione, Testosterone to Androstenedione ratio

  • Follicular number [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean follicular number

  • Gonadotrophins [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Follicular Stimulating Hormone (FSH), Luteneizing Hormone (LH), LH to FSH ratio


Estimated Enrollment: 200
Study Start Date: January 2004
Estimated Study Completion Date: December 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCOS obese Orlistat
Obese PCOS women treated with Orlistat, diet and physical exercise
 Drug: Orlistat
Tablet, 120 mg, three times daily, for six months
Experimental: Obese Orlistat
Obese women (non PCOS) treated with Orlistat, diet and physical exercise
 Drug: Orlistat
Tablet, 120 mg, three times daily, for six months
Experimental: PCOS obese diet
Obese PCOS women treated with diet and physical exercise
 Behavioral: Diet and physical exercise
Hypocaloric diet and regular physical exercise
Experimental: PCOS obese Sibutramine
Obese PCOS women treated with Sibutramine, diet and physical exercise
 Drug: Sibutramine
Tablet, 10 mg, once daily, for six months

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • premenopausal,
  • nonpregnant,
  • nonlactating,
  • overweight and obese women

Exclusion Criteria:

  • classical 21-hydroxylase deficiency,
  • hyperprolactinemia,
  • adrenal or ovarian tumor and Cushing's disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475019

Locations
Greece
Aristotle University of Thessaloniki Medical School
Thessaloniki, Greece, 54124
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Study Director: Dimitrios Panidis, PhD Aristotle University of Thessaloniki Medical School
  More Information

No publications provided

Responsible Party: C.VOSNAKIS, Obstetrician- Gynecologist, Scientific Assosiate of Medical School of Aristotle University, Thessaloniki, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01475019     History of Changes
Other Study ID Numbers: A1732,2011
Study First Received: November 14, 2011
Last Updated: November 18, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Aristotle University Of Thessaloniki:
Obesity
Polycystic Ovaries Syndrome
Orlistat
 Sibutramine
Androgen levels
Insulin resistance

Additional relevant MeSH terms:
Obesity
Polycystic Ovary Syndrome
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Body Weight Changes
Sibutramine
Orlistat
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013