Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function

NCT01257984 | Completed Phase 3

• 2 other identifiers: 147012010-019902-17
• Study Type: interventional
• Target: 508
• Locations: 5 countries
• Sites: 43

Brief Summary

The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time

  12 months

Secondary Outcomes (3)

• Number of delayed and missed pills

  12 months

• Bleeding pattern and cycle control parameters

  12 months

• Length of the tablet break and the length of the bleeding episode preceding the tablet break

  12 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: BAY86-5300

Arm 2

EXPERIMENTAL

Drug: BAY86-5300

Interventions

BAY86-5300 DRUG

0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function

Arm 1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection

You may not qualify if:

• Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
• Body mass index (BMI) \>/= 30.0 kg/m2
• Presence or a history of venous or arterial thrombotic/thromboembolic events
• Repeated measurements of systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg.
• Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous COC use
• Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
• Severe dyslipoproteinemia
• Malignant or premalignant disease
• Uncontrolled thyroid disorder
• Chronic inflammatory bowel disease
• Severe renal insufficiency or acute renal failure
• History of migraine with focal neurologic symptoms
• Epilepsy

Sponsors & Collaborators

• Bayer: lead

Study Sites (43)

Unknown Facility

Paris, Paris, 75018, France

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Biarritz, 64200, France

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Marly-le-Roi, 78160, France

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Nancy, 54000, France

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Olivet, 45160, France

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Paris, 75 009, France

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Paris, 75 017, France

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Paris, 75007, France

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Strasbourg, 67 000, France

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Toulouse, 31000, France

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Heidelberg, Baden-Wurttemberg, 69115, Germany

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Hamburg, Hamburg, 20357, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Wuppertal, North Rhine-Westphalia, 42103, Germany

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Blankenburg, Saxony-Anhalt, 38889, Germany

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Burg, Saxony-Anhalt, 39288, Germany

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Magdeburg, Saxony-Anhalt, 39130, Germany

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Gera, Thuringia, 07545, Germany

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Kahla, Thuringia, 07768, Germany

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Bologna, 40138, Italy

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Brescia, 25123, Italy

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Cagliari, 09124, Italy

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Catania, 95123, Italy

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Milan, 20154, Italy

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Modena, 41124, Italy

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Napoli, 80138, Italy

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Palermo, 90127, Italy

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Pavia, 27100, Italy

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Pisa, 56126, Italy

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Roma, 00189, Italy

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Siena, 53100, Italy

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Elda, Alicante, 03600, Spain

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Barcelona, Barcelona, 08019, Spain

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Córdoba, Córdoba, 14004, Spain

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Boadilla del Monte, Madrid, 28660, Spain

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Málaga, Málaga, 29013, Spain

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Chesterfield, Derbyshire, S40 4TF, United Kingdom

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Nottingham, Nottinghamshire, NG2 4PJ, United Kingdom

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Bath, Somerset, BA1 2SR, United Kingdom

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East Horsley, Surrey, KT24 6QT, United Kingdom

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Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom

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Corsham, Wiltshire, SN3 9DL, United Kingdom

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Cardiff, CF5 4AD, United Kingdom

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Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

FR (10); DE (9); IT (12); ES (5); GB (7)