NCT02984722

Brief Summary

The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 3, 2016

Last Update Submit

December 6, 2016

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSmetformin

Outcome Measures

Primary Outcomes (1)

  • Gastro intestinal disorders

    6 months

Secondary Outcomes (10)

  • number of cycles in 6 months of therapy

    6 months

  • insulin levels

    6 months

  • hirsutism score

    6 months

  • androstenedione levels

    6 months

  • testosterone levels

    6 months

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

PCOS women treated with 1500 mg/die of extended-release metformin

Drug: Metformin

2

EXPERIMENTAL

PCOS women treated with 1500 mg/die of immediate-release metformin

Drug: Metformin

Interventions

MetforminDRUG
12

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with PCOS in accordance with Rotterdam criteria

You may not qualify if:

  • pregnancy
  • diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
  • past history of cardiovascular diseases
  • past history of gastro-intestinal diseases
  • significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal);
  • neoplasms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic university of Sacred Heart

Rome, Rome, 00168, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 3, 2016

First Posted

December 7, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

IT(1)