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

This study has been completed.
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00374387
First received: September 8, 2006
Last updated: March 30, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Healthy
Drug: Nuvaring
Drug: low-dose combination pill
Drug: minipill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Parameters about sexual desire and psychosocial, relational en sexual parameters.

Estimated Enrollment: 150
Study Start Date: September 2006
Study Completion Date: March 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374387

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Fund for Scientific Research, Flanders, Belgium
Investigators
Principal Investigator: Petra De Sutter, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Petra De Sutter, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00374387     History of Changes
Other Study ID Numbers: 2006/309
Study First Received: September 8, 2006
Last Updated: March 30, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Healthy women

ClinicalTrials.gov processed this record on April 17, 2014