Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01200186
First received: August 13, 2010
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.
| Condition | Intervention | Phase |
|---|---|---|
|
Contraceptives, Oral |
Drug: EV/DNG (Qlaira, BAY86-5027) Drug: Progestin Only Pills |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction |
Resource links provided by NLM:
MedlinePlus related topics:
Birth Control
Drug Information available for:
Ethinyl Estradiol
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities. [ Time Frame: up to 12 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to event for discontinuation due to reasons other than bleeding irregularities [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
- Time to event for discontinuation due to reasons other than bleeding irregularities [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
- Number of intracyclic bleeding [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
- Number of intracyclic bleeding [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
- Number of heavy and/or prolonged bleeding [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
- Number of heavy and/or prolonged bleeding [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
- Number of unintended pregnancies [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
- Number of unintended pregnancies [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
- Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
- Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
- Global assessment of well-being and satisfaction [ Time Frame: Month 3-5 ] [ Designated as safety issue: No ]
- Global assessment of well-being and satisfaction [ Time Frame: Month 6-12 ] [ Designated as safety issue: No ]
- Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy [ Time Frame: up to 12 Months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1 |
Drug: EV/DNG (Qlaira, BAY86-5027)
At the discretion of the attending physician
|
| Group 2 |
Drug: Progestin Only Pills
At the discretion of the attending physician
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Women in gynecological practice
Criteria
Inclusion Criteria:
- Women between 18-50 years
- Women who used ethinylestradiol containing oral contraceptives for at least the three preceding months before the study
- Women who decided to start Qlaira® or a Progestin Only Pill. The prescription of the hormonal contraceptive is made at the discretion of the attending physician and has to be documented
Exclusion Criteria:
- Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
- Women who are breast-feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200186
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| Austria | |
| Withdrawn | |
| Many Locations, Austria | |
| Czech Republic | |
| Recruiting | |
| Many Locations, Czech Republic | |
| France | |
| Recruiting | |
| Many Locations, France | |
| Germany | |
| Recruiting | |
| Many Locations, Germany | |
| Greece | |
| Recruiting | |
| Many Locations, Greece | |
| Hungary | |
| Recruiting | |
| Many Locations, Hungary | |
| Israel | |
| Not yet recruiting | |
| Many locations, Israel | |
| Italy | |
| Recruiting | |
| Many Locations, Italy | |
| Norway | |
| Withdrawn | |
| Many Locations, Norway | |
| Russian Federation | |
| Recruiting | |
| Many Locations, Russian Federation | |
| Slovakia | |
| Recruiting | |
| Many Locations, Slovakia | |
| Sweden | |
| Recruiting | |
| Many Locations, Sweden | |
| United Kingdom | |
| Recruiting | |
| Many Locations, United Kingdom | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Global Medical Affairs, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT01200186 History of Changes |
| Other Study ID Numbers: | 15217, QL0901 |
| Study First Received: | August 13, 2010 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Austria: Ministry of Health France: French Data Protection Authority Hungary: National Institute of Pharmacy Czech Republic: State Institute for Drug Control Finland: Ethics Committee Greece: Ministry of Health and Welfare Latvia: State Agency/Medicines and EC Lithuania: State Agency/Medicines and EC Czech Republic: Association of Innovative Pharma industry Germany: The Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Russian Federation: Independent EC - approval; The Ministry of Health - notification Slovakia: Ethics Committee Sweden: Regional Ethics Review Board of Uppsala Israel: Ethics Commission United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Ethinyl Estradiol Progestins Estrogens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013