NCT01519401

Brief Summary

The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS). The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

January 23, 2012

Last Update Submit

July 22, 2020

Conditions

Polycystic Ovary SyndromeEstro-progestin Drugs

Keywords

PCOSdrospirenone ethinylestradiolandrogensmetabolism

Outcome Measures

Primary Outcomes (1)

  • To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women

    hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile

    twelve months

Study Arms (2)

3 mg drospirenone and 20 µg ethinyl-estradiol

ACTIVE COMPARATOR
Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol

3 mg drospirenone and 30 µg ethinyl-estradiol

ACTIVE COMPARATOR
Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol

Interventions

3 mg drospirenone and 20 µg ethinyl-estradiolDRUG
3 mg drospirenone and 20 µg ethinyl-estradiol
3 mg drospirenone and 30 µg ethinyl-estradiolDRUG
3 mg drospirenone and 30 µg ethinyl-estradiol

Eligibility Criteria

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

You may qualify if:

  • normal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003.

You may not qualify if:

  • pregnancy
  • past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension
  • significant liver or renal impairment
  • other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
  • neoplasms
  • unstable mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Related Publications (1)

  • Romualdi D, De Cicco S, Busacca M, Gagliano D, Lanzone A, Guido M. Clinical efficacy and metabolic impact of two different dosages of ethinyl-estradiol in association with drospirenone in normal-weight women with polycystic ovary syndrome: a randomized study. J Endocrinol Invest. 2013 Sep;36(8):636-41. doi: 10.1007/BF03346756.

    PMID: 24105072DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

drospirenoneEthinyl Estradiol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

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

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 26, 2012

Study Start

February 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

IT(1)