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

September 8, 2006
March 30, 2011
September 2006
August 2009   (final data collection date for primary outcome measure)
Parameters about sexual desire and psychosocial, relational en sexual parameters.
Same as current
Complete list of historical versions of study NCT00374387 on ClinicalTrials.gov Archive Site
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Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire
Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Nuvaring
  • Drug: low-dose combination pill
  • Drug: minipill
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
March 2011
August 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00374387
2006/309
No
Petra De Sutter, University Hospital Ghent
University Hospital, Ghent
Fund for Scientific Research, Flanders, Belgium
Principal Investigator: Petra De Sutter, MD, PhD University Hospital, Ghent
University Hospital, Ghent
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP