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Contraceptive Pill and Hormonal Vaginal Ring in Women With Polycystic Ovary Syndrome

NCT01588873 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2012-05-04

No results posted yet for this study

Summary

The main aims of this study are:

* to investigate and compare the effects of long lasting use (59 weeks) of vaginal and oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid profile, and serum levels of SHBG and hs-CRP in women with PCOS.
* to compare the metabolic effects of oral and vaginal combined contraceptives and to find out whether oral or transvaginal contraceptive can be recommended to a particular group of women, for example in women with increased metabolic risks.
* to clarify whether the unfavourable effects of combined contraceptives diminish with time (after use of one year).

Conditions

  • Adverse Effect of Oral Contraceptives, Sequela

Interventions

DRUG

oc:E-E-desogestrel/vaginal ring:E-E -ethonogestrel

The OC or vaginal ring will be used in 9 weeks periods followed by one week's break each. After a wash-out period of at least 2 months of any previous hormonal contraceptives all examinations will be performed at the 1st to 5th day of the menstruation cycle at baseline and then at the 9th, 29th and 59th week and the last 1 month after stopping contraception. Blood samples will be collected between 07 and 10 AM after an overnight fast and during the follicular phase or at any time in cases of amenorrhea. After centrifugation serum is filled in eight tubes with at least 2 ml of serum in each, and immediately frozen at -70ºC as well as one tube of plasma. Every tube will be marked appropriately. Fasting plasma glucose and HbA1c will be analysed at once at every appointment.

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Laure C Morin-Papunen · University of Oulu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588873 on ClinicalTrials.gov