Clinical Trials Logo

Clinical 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. 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02257671
Study type Interventional
Source Karolinska University Hospital
Contact Angelica L Hirschberg, Professor
Phone +46 8 517 733 26
Email angelica.linden-hirschberg@karolinska.se
Status Recruiting
Phase N/A
Start date February 2012
Completion date December 2015

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06394999 - Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive Phase 3
Completed NCT00653016 - An Open-label, Multicentre Study on Preference and Satisfaction of Canadian Women for the Transdermal Contraceptive Patch vs. Previous Primary Contraceptive Method Phase 4
Completed NCT00511784 - Relative Risks for Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-containing Oral Contraceptives. N/A
Completed NCT00236769 - A Study of Efficacy and Safety With the Transdermal Contraceptive System. Phase 3
Active, not recruiting NCT03124160 - Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard Phase 3
Completed NCT00709189 - Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women. Phase 1
Completed NCT00258063 - A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive) Phase 1
Completed NCT00775086 - Bioequivalence Study of Patches With Different Equilibration Profiles Phase 1
Recruiting NCT04143659 - A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception Phase 1
Completed NCT00697307 - Bioequivalence Study of Patches With Different Release Profiles N/A
Completed NCT00261482 - Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception. Phase 4
Completed NCT01286948 - Prevention of Ovulation Achieved by Single Intra-vaginal Administration of Levogel as Compared to Oral LNG Phase 1
Completed NCT00236795 - A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil. Phase 3
Completed NCT01833793 - Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice N/A
Recruiting NCT03432416 - Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring Phase 2
Completed NCT01178125 - A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy Phase 3
Completed NCT00254865 - A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers Phase 1
Completed NCT00258076 - A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch) Phase 1
Completed NCT00331071 - Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks N/A
Completed NCT00377988 - A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control N/A