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

NCT01200186 | Completed

• 2 other identifiers: 15217QL0901
• Study Type: observational
• Target: 3,258
• Locations: 11 countries
• Sites: 11

Brief 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.

Conditions

Contraceptives, Oral

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.

  up to 12 Months

Secondary Outcomes (13)

• Time to event for discontinuation due to reasons other than bleeding irregularities

  Month 3-5

• Time to event for discontinuation due to reasons other than bleeding irregularities

  Month 6-12

• Number of intracyclic bleeding

  Month 3-5

• Number of intracyclic bleeding

  Month 6-12

• Number of heavy and/or prolonged bleeding

  Month 3-5

Study Arms (2)

Group 1

Drug: EV/DNG (Qlaira, BAY86-5027)

Group 2

Drug: Progestin Only Pills

Interventions

EV/DNG (Qlaira, BAY86-5027) DRUG

At the discretion of the attending physician

Group 1

Progestin Only Pills DRUG

At the discretion of the attending physician

Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women in gynecological practice

You may qualify if:

• 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

You may not qualify if:

• Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
• Women who are breast-feeding

Sponsors & Collaborators

• Bayer: lead

Study Sites (11)

Unknown Facility

Many Locations, Czechia

Location

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Greece

Location

Unknown Facility

Many Locations, Hungary

Location

Unknown Facility

Many Locations, Israel

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Russia

Location

Unknown Facility

Many Locations, Slovakia

Location

Unknown Facility

Many Locations, Sweden

Location

Unknown Facility

Many Locations, United Kingdom

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: September 13, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

SL (1); GR (1); RU (1); HU (1); CZ (1); FR (1); IT (1); DE (1); SE (1); IL (1); GB (1)