Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire

March 30, 2011 updated by: University Hospital, Ghent

75 heterosexual women are asked to use 3 different types of contraception (Nuvaring, low-dose combination pill, minipill), each during 3 months. On a monthly basis, questionnaires are filled out about sexual desire and psychosocial, relational en sexual parameters. Also the sexual desire of the partner is questioned. On a three-monthly basis, blood samples are drawn to determine changes in hormonal parameters (one sample per product period).

75 lesbian women are doing the same trial, but during an extra 3 months period, they are asked to have their natural menstrual cyclus as a control condition. Blood samples during these extra months will be drawn at the third or fourth day after start of the menses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Heterosexual or lesbian women
  • Aged between 18 and 45 years
  • Stable monogameous relationship
  • Normal menstrual cyclus

Exclusion Criteria:

  • Polycystic ovarial syndrome
  • Normal exclusion criteria for the use of contraception
  • Use of medication known to influence sexual desire and/or androgen levels
  • Women who wants to become pregnant, are pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Parameters about sexual desire and psychosocial, relational en sexual parameters.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Fund for Scientific Research, Flanders, Belgium

Investigators

  • Principal Investigator: Petra De Sutter, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 8, 2006

First Submitted That Met QC Criteria

September 8, 2006

First Posted (Estimate)

September 11, 2006

Study Record Updates

Last Update Posted (Estimate)

March 31, 2011

Last Update Submitted That Met QC Criteria

March 30, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006/309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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