Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

Contraceptives, Oral Clinical Trial

Official title:

Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200186
• Other study ID #: 15217
• Secondary ID: QL0901
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2010
• Last updated: October 15, 2015
• Start date: October 2010
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ministry of HealthFrance: French Data Protection AuthorityHungary: National Institute of PharmacyCzech Republic: State Institute for Drug ControlFinland: Ethics CommitteeGreece: Ministry of Health and WelfareLatvia: State Agency/Medicines and ECLithuania: State Agency/Medicines and ECCzech Republic: Association of Innovative Pharma industryGermany: The Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteeRussian Federation: Independent EC - approval; The Ministry of Health - notificationSlovakia: Ethics CommitteeSweden: Regional Ethics Review Board of UppsalaIsrael: Ethics CommissionUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3258
• Est. completion date: October 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraceptives, Oral

Intervention

Drug:
• EV/DNG (Qlaira, BAY86-5027)
At the discretion of the attending physician
• Progestin Only Pills
At the discretion of the attending physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Russian Federation,  Slovakia,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.		up to 12 Months	No
Secondary	Time to event for discontinuation due to reasons other than bleeding irregularities		Month 3-5	No
Secondary	Time to event for discontinuation due to reasons other than bleeding irregularities		Month 6-12	No
Secondary	Number of intracyclic bleeding		Month 3-5	No
Secondary	Number of intracyclic bleeding		Month 6-12	No
Secondary	Number of heavy and/or prolonged bleeding		Month 3-5	No
Secondary	Number of heavy and/or prolonged bleeding		Month 6-12	No
Secondary	Number of unintended pregnancies		Month 3-5	No
Secondary	Number of unintended pregnancies		Month 6-12	No
Secondary	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		Month 3-5	No
Secondary	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		Month 6-12	No
Secondary	Global assessment of well-being and satisfaction		Month 3-5	No
Secondary	Global assessment of well-being and satisfaction		Month 6-12	No
Secondary	Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy		up to 12 Months	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here and search for websynopsis results posting provided by Bayer.