Data on Oral Contraceptives Compliance in Non Stop Regimen

NCT01185678 | Completed

• 2 other identifiers: 15253WH1011PL
• Study Type: observational
• Target: 8,416
• Locations: 1 country
• Sites: 1

Brief Summary

Adherence to the dosing scheme is the principal element of COC efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study is to evaluate in everyday practice the relation between dosage errors and indicated factors, potentially influencing the compliance with the dosing scheme.

Conditions

Contraception

Keywords

Contraception; Compliance

Outcome Measures

Primary Outcomes (1)

• The percentage of users showing noncompliant behaviors

  3 consecutive cycles (28-days per cycle)

Secondary Outcomes (2)

• The characteristics of noncompliant behavior.

  3 consecutive cycles (28-days per cycle)

• The relation between noncompliant behavior and selected factors.

  3 consecutive cycles (28-days per cycle)

Study Arms (1)

Group1

Drug: Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill)

Interventions

Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill) DRUG

One tablet per day, orally, 28 tablets per cycle, during three consecutive cycles.

Group1

Eligibility Criteria

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

Study Population

Gynecological practices ptients - starters or current users.

You may qualify if:

• Patients at the age of 18-50 requiring contraception, treated with oral contraceptives designed for the scheme 28 pills for 28 days. The decisions would be made at the discretion of the attending physician.

You may not qualify if:

• Patients were not valid for analysis if the initial visit was before start of study in the country (retrospective documentation), or if they did not take oral contraceptives designed for the scheme 28 pills for 28 days.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Poland

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

drospirenone and ethinyl estradiol combination; Contraceptives, Oral, Combined; Desogestrel

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 20, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

PL (1)