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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014