---
title: Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome
nct_id: NCT01459445
overall_status: UNKNOWN
phase: NA
sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
study_type: INTERVENTIONAL
primary_condition: Polycystic Ovary Syndrome
countries: Romania
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01459445.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01459445"
ct_last_update_post_date: 2011-10-25
last_seen_at: "2026-05-12T06:26:09.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome

**Official Title:** Metformin Plus EE30µg-drospirenone and Weight Loss- Impact on Endothelial Function and hsCRP Levels in PCOS

**NCT ID:** [NCT01459445](https://clinicaltrials.gov/study/NCT01459445)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 26
- **Lead Sponsor:** Iuliu Hatieganu University of Medicine and Pharmacy
- **Conditions:** Polycystic Ovary Syndrome, Endothelial Dysfunction
- **Start Date:** 2011-02
- **Completion Date:** 2012-01
- **CT.gov Last Update:** 2011-10-25

## Brief Summary

The purpose of this study is to assess the effects of ethinylestradiol 30µg-drospirenone combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunction (i.e. flow-mediated dilation and serum endothelin-1), serum hsCRP,lipids,insulin resistance and body composition in young women with PCOS.

## Detailed Description

Women with polycystic ovary syndrome (PCOS) frequently cluster several cardiovascular risk markers and early subclinical atherosclerosis. Because combined oral contraceptives (COCs), the most common treatment of this disease, might adversely influence insulin resistance, glucose tolerance, lipid profile or aggravate chronic inflammation the possibility of worsening the already unfavorable cardiovascular risk profile of PCOS subjects is of concern. On the contrary, the insulin sensitizer metformin has been shown to ameliorate insulin resistance, reduce hyperandrogenism and triglyceride levels and also to improve endothelial structure and function in PCOS. Drospirenone (DRP) is a progestin with antiandrogenic and antimineralocorticoid activity. However, the studies assessing the effect of the COC containing 30 µg EE+3mg DRP (DRP/EE30µg) on surrogate markers of atherosclerosis are few and inconclusive. Therefore,the purpose of the present study is to assess the effects of the oral contraceptive DRP/EE30µg combined with metformin and weight loss by means of dietary intervention on the indices of endothelial dysfunction, i.e. flow-mediated dilation and serum endothelin-1, serum hsCRP,lipids, and insulin resistance in young women with PCOS.

## Eligibility

- **Minimum age:** 15 Years
- **Maximum age:** 35 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* women with diagnosis of polycystic ovary syndrome defined according to Androgen Excess Society 2006 guidelines

Exclusion Criteria:

* secondary causes of hyperandrogenism such as hyperprolactinemia, thyroid disease, androgen-secreting tumours, Cushing's syndrome and congenital adrenal hyperplasia
* current or previous use (within 6 months) of oral contraceptives, anti-androgens, ovulation induction medications
* use of drugs known to affect carbohydrate-lipid metabolism or inflammation (anti-inflammatory drugs) at the time of evaluation and during the last one month preceding the evaluations
* concurrent minor infection reported during the last one month preceding the evaluations
* personal history of diabetes mellitus
```

## Arms

- **Metformin+Drospirenone / EE 30µg** (OTHER)

## Interventions

- **Metformin, Ethinylestradiol 30µg-Drospirenone** (DRUG) — Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months

## Primary Outcomes

- **flow-mediated dilation** _(time frame: six months)_

## Secondary Outcomes

- **endothelin-1** _(time frame: six months)_
- **hsCRP** _(time frame: six months)_
- **insulin resistance indices** _(time frame: six months)_
- **body composition** _(time frame: six months)_
- **lipid profile** _(time frame: six months)_
- **total testosterone** _(time frame: six months)_
- **sex hormone-binding globulin** _(time frame: six months)_
- **systolic blood pressure and diastolic blood pressure** _(time frame: six months)_

## Locations (1)

- Clinic of Endocrinology, Cluj-Napoca, Cluj, Romania

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.clinic of endocrinology|cluj-napoca|cluj|romania` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01459445.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01459445*  
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