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

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ClinicalTrials.gov Identifier: NCT00374387
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : March 31, 2011
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by:
University Hospital, Ghent

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Drug: Nuvaring Drug: low-dose combination pill Drug: minipill Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire
Study Start Date : September 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Petra De Sutter, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00374387     History of Changes
Other Study ID Numbers: 2006/309
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: March 31, 2011
Last Verified: March 2011

Keywords provided by University Hospital, Ghent:
Healthy women