HealthyNCT00374387
Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire
A study testing Nuvaring, low-dose combination pill and minipill in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nuvaring, low-dose combination pill and minipill
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2006to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Heterosexual or lesbian women
- Aged between 18 and 45 years
- Stable monogameous relationship
- Normal menstrual cyclus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Nuvaring, low-dose combination pill, minipill
- Keywords
- Healthy women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuvaringDrug
low-dose combination pillDrug
minipillDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters about sexual desire and psychosocial, relational en sexual parameters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Investigators
- Petra De Sutter, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374387
- Sponsor's protocol ID
- 2006/309
- Status last verified
- Mar 2011
- First submitted
- 8 Sep 2006
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire
- ClinicalTrials.gov ID
- NCT00374387
- Acronym / sponsor ID
- 2006/309
- Conditions
- Healthy
- Keywords
- Healthy women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- Sep 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Heterosexual or lesbian women
- Aged between 18 and 45 years
- Stable monogameous relationship
- Normal menstrual cyclus
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuvaring | Drug | – |
| low-dose combination pill | Drug | – |
| minipill | Drug | – |
Primary outcome
Parameters about sexual desire and psychosocial, relational en sexual parameters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2011.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra De Sutter, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuvaring, low-dose combination pill and minipill in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters about sexual desire and psychosocial, relational en sexual parameters.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2011.