Clinical trial NCT00266032: Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
Official title: A Multicenter, Open, Randomized, Parallel Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Variations of an Extended Regimen vs. a Standard Regimen (24 + 4 Days) in 1122 Healthy Female Volunteers for One Year, Followed by a One Year Safety Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-12-15
Enrollment: 1166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG (BSP AG), Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed from result posting as it is covered by the Adverse Event section.

Eligibility criteria: Inclusion Criteria:

* Healthy women who desire contraception
* smokers ≤ 30 Years old

Exclusion Criteria:

* Contraindication against use of hormonal contraceptives

Primary outcomes:
measure: Number of Days With Bleeding Including Spotting
timeFrame: up to 1 year
measure: Number of Unintended Pregnancies in Yaz Flexible Arm
timeFrame: up to 2 years
measure: Pearl Index
timeFrame: Up to 2 years
measure: Number of Unintended Pregnancies Due to Method Failure
timeFrame: Up to 2 years
measure: Adjusted Pearl Index
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of Days With Bleeding Excluding Spotting
timeFrame: up to 1 year
measure: Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days
timeFrame: up to 1 year
measure: Number of Bleeding / Spotting Days by 90-day Reference Period
timeFrame: up to 1 year
measure: Number of Bleeding / Spotting Episodes in 90 Day Reference Period
timeFrame: Up to one year
measure: Days With Scheduled Versus Unscheduled Bleeding
timeFrame: Up to one year
Other outcomes:
Locations:
city: Drummondville
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Shawinigan
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Ettlingen
country: Germany
state: Baden-Württemberg
city: Karlsruhe
country: Germany
state: Baden-Württemberg
city: Ansbach
country: Germany
state: Bayern
city: Krumbach
country: Germany
state: Bayern
city: Nürnberg
country: Germany
state: Bayern
city: Dietzenbach
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Mühlheim
country: Germany
state: Hessen
city: Bovenden
country: Germany
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Osnabrück
country: Germany
state: Niedersachsen
city: Bernburg
country: Germany
state: Sachsen-Anhalt
city: Jessen
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Wurzen
country: Germany
state: Sachsen
city: Gera
country: Germany
state: Thüringen
city: Jena
country: Germany
state: Thüringen
city: Kahla
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Groningen
country: Netherlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Long-term tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):84-93. doi: 10.1136/jfprhc-2011-100214.
citation: Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Contraceptive efficacy and tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):73-83. doi: 10.1136/jfprhc-2011-100213.
citation: Reif S, Snelder N, Blode H. Characterisation of the pharmacokinetics of ethinylestradiol and drospirenone in extended-cycle regimens: population pharmacokinetic analysis from a randomised Phase III study. J Fam Plann Reprod Health Care. 2013 Apr;39(2):e1-13. doi: 10.1136/jfprhc-2012-100397.