NCT01475019

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4 obesity

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 21, 2011

Status Verified

November 1, 2011

Enrollment Period

6 years

First QC Date

November 14, 2011

Last Update Submit

November 18, 2011

Conditions

ObesityPolycystic Ovaries Syndrome

Keywords

ObesityPolycystic Ovaries SyndromeOrlistatSibutramineAndrogen levelsInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • Anti- Mullerian hormone (AMH) levels

    6 months

Secondary Outcomes (4)

  • Weight loss

    6 months

  • Androgen levels

    6 months

  • Follicular number

    6 months

  • Gonadotrophins

    6 months

Study Arms (4)

PCOS obese Orlistat

EXPERIMENTAL

Obese PCOS women treated with Orlistat, diet and physical exercise

Drug: Orlistat

Obese Orlistat

EXPERIMENTAL

Obese women (non PCOS) treated with Orlistat, diet and physical exercise

Drug: Orlistat

PCOS obese diet

EXPERIMENTAL

Obese PCOS women treated with diet and physical exercise

Behavioral: Diet and physical exercise

PCOS obese Sibutramine

EXPERIMENTAL

Obese PCOS women treated with Sibutramine, diet and physical exercise

Drug: Sibutramine

Interventions

OrlistatDRUG

Tablet, 120 mg, three times daily, for six months

Obese OrlistatPCOS obese Orlistat
SibutramineDRUG

Tablet, 10 mg, once daily, for six months

PCOS obese Sibutramine
Diet and physical exerciseBEHAVIORAL

Hypocaloric diet and regular physical exercise

PCOS obese diet

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • classical 21-hydroxylase deficiency,
  • hyperprolactinemia,
  • adrenal or ovarian tumor and Cushing's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aristotle University of Thessaloniki Medical School

Thessaloniki, Thessaloniki, 54124, Greece

Location

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

OrlistatsibutramineDietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dimitrios Panidis, PhD

    Aristotle University of Thessaloniki Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrician- Gynecologist, Scientific Assosiate of Medical School of Aristotle University, Thessaloniki

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 21, 2011

Study Start

January 1, 2004

Primary Completion

January 1, 2010

Study Completion

December 1, 2012

Last Updated

November 21, 2011

Record last verified: 2011-11

Locations

GR(1)