Female ContraceptionP-piller101NCT02257671
Oral Contraceptives and Economic Behaviour
A study testing Oral contraceptive in people with Female Contraception, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood, sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400 healthy women will be randomized to OC or placebo for a period of three months. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Contraception
- What is being tested?
- Oral contraceptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Dec 2015
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young women, aged 18-35 years, BMI 19-30
Who cannot join
- Risk factors for thrombosis, smoking, obesity, hypertension, diabetes and estrogen/gestagen therapy the last three months
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, 171 76
Angelica L Hirschberg, Professor, +46 8 517 733 26, angelica.linden-hirschberg@karolinska.se
About this study
Official title: The Influence of Oral Contraceptives on Mood, Sexuality and Economic Behavior
The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood, sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400 healthy women will be randomized to OC or placebo for a period of three months. Before and at the end of treatment, mood and sexuality will be assessed by validated instruments. At the end of treatment, each woman will participate in behavioral experiments testing self-confidence, risk taking and altruism. The current project could fill the gap of ignorance about causal effects of OCs on mood, sexuality and behavior. The results might improve current practice as regards information about OCs, choice of hormonal contraceptive, regimen and duration of use. As a consequence, this could lead to reduced discontinuation rate, fewer unintended pregnancies and abortions. The project will contribute to an overall improvement in women's reproductive health.
- Conditions
- Female Contraception
- Being tested
- Oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral contraceptiveDrug
Also called ethinylestradiol + levonorgestrel
Neovletta
| Study group | Role | What they receive |
|---|---|---|
| Oral contraceptive | Active comparator | oral dose of ethinylestradiol 0.03 mg + levonorgestrel 0.15 mg per day during 11 weeks Receives: Drug: Oral contraceptive |
| Placebo | Placebo comparator | Oral placebo capsule daily during 11 weeks Receives: Drug: Oral contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
economic behaviour
A modified dictator game will be used to measure altruistic behavior (Eckel and Grossman 1996). Each subject decides how to allocate money between herself and a charitable organisation. The size of the donation is our measure of altruism. Risk aversion is measured by a test where the subject makes several choices between a certain payoff and a 50/50 gamble to win a certain amount of money (Dohmen et al 2005). Competitiveness is defined as the extent to which women choose to compete in a task which involves solving as many simple mathematical exercises as possible during three minutes (Niederle and Vesterlund 2007).
Measured: 11 weeks
sexual behaviour
Sexual function will be assessed by the validated instruments Sexual Activity Log (SAL) (Derogatis et al 2004), Profile of Female Sexual Function (PFSF) (McHorney et al 2004, Derogatis et al 2004) and Personal Distress Scale (PDS, past 30 days) (Derogatis et al 2004, Leiblum et al 2006). The women are answering the questionnaires, which are all computerized, at the Women´s Health Research Unit.
Measured: baseline to 11 weeks
mood
Mood and health-related quality of life will be assessed by the Beck Depression Inventory (BDI) test (Lightfoot and Oliver 1985) and the Psychological General Well-Being Index (PGWB) (Dupuy 1984, Wiklund et al 1992).
Measured: baseline to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startFeb 2012
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female ContraceptionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Angelica Lindén Hirschberg, Karolinska University Hospital
- Investigators
- Angelica L Hirschberg, Professor, Principal investigator, Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257671
- Sponsor's protocol ID
- 2010-020824-23
- Acronym
- P-piller101
- Status last verified
- Oct 2014
- First submitted
- 28 Sep 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Oral Contraceptives on Mood, Sexuality and Economic Behavior
- ClinicalTrials.gov ID
- NCT02257671
- Acronym / sponsor ID
- P-piller101 / 2010-020824-23
- Conditions
- Female Contraception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 Oct 2014 (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.
The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood, sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400 healthy women will be randomized to OC or placebo for a period of three months. Before and at the end of treatment, mood and sexuality will be assessed by validated instruments. At the end of treatment, each woman will participate in behavioral experiments testing self-confidence, risk taking and altruism. The current project could fill the gap of ignorance about causal effects of OCs on mood, sexuality and behavior. The results might improve current practice as regards information about OCs, choice of hormonal contraceptive, regimen and duration of use. As a consequence, this could lead to reduced discontinuation rate, fewer unintended pregnancies and abortions. The project will contribute to an overall improvement in women's reproductive health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral contraceptive | Active comparator | Drug: Oral contraceptiveoral dose of ethinylestradiol 0.03 mg + levonorgestrel 0.15 mg per day during 11 weeks |
| Placebo | Placebo comparator | Drug: Oral contraceptiveOral placebo capsule daily during 11 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young women, aged 18-35 years, BMI 19-30
Key exclusion criteria (1 listed)
- Risk factors for thrombosis, smoking, obesity, hypertension, diabetes and estrogen/gestagen therapy the last three months
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 |
|---|---|---|
| Oral contraceptiveAlso: ethinylestradiol + levonorgestrelNeovletta | Drug | Oral contraceptive, Placebo |
Primary outcome
economic behaviour
Time frame: 11 weeks
A modified dictator game will be used to measure altruistic behavior (Eckel and Grossman 1996). Each subject decides how to allocate money between herself and a charitable organisation. The size of the donation is our measure of altruism. Risk aversion is measured by a test where the subject makes several choices between a certain payoff and a 50/50 gamble to win a certain amount of money (Dohmen et al 2005). Competitiveness is defined as the extent to which women choose to compete in a task which involves solving as many simple mathematical exercises as possible during three minutes (Niederle and Vesterlund 2007).
sexual behaviour
Time frame: baseline to 11 weeks
Sexual function will be assessed by the validated instruments Sexual Activity Log (SAL) (Derogatis et al 2004), Profile of Female Sexual Function (PFSF) (McHorney et al 2004, Derogatis et al 2004) and Personal Distress Scale (PDS, past 30 days) (Derogatis et al 2004, Leiblum et al 2006). The women are answering the questionnaires, which are all computerized, at the Women´s Health Research Unit.
mood
Time frame: baseline to 11 weeks
Mood and health-related quality of life will be assessed by the Beck Depression Inventory (BDI) test (Lightfoot and Oliver 1985) and the Psychological General Well-Being Index (PGWB) (Dupuy 1984, Wiklund et al 1992).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
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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.
Angelica L Hirschberg, Professor principal investigator
Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral contraceptive in people with Female Contraception, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Oct 2014. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelica L Hirschberg, Professor (+46 8 517 733 26, angelica.linden-hirschberg@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
economic behaviour (time frame: 11 weeks). The study lists 3 primary outcomes in all. 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 6 Oct 2014.