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Trial record 48 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

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

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ClinicalTrials.gov Identifier: NCT01257984
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: BAY86-5300 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Randomized, Controlled, Two-arm Study to Assess Compliance With Daily Tablet Intake of Women on Treatment With the Oral Contraceptive SH T00186D/BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function Over 12 Months
Study Start Date : December 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Arm 1 Drug: BAY86-5300
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

Experimental: Arm 2 Drug: BAY86-5300
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 without reminder support




Primary Outcome Measures :
  1. Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of delayed and missed pills [ Time Frame: 12 months ]
  2. Bleeding pattern and cycle control parameters [ Time Frame: 12 months ]
  3. Length of the tablet break and the length of the bleeding episode preceding the tablet break [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257984


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Locations
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France
Biarritz, France, 64200
Marly Le Roi, France, 78160
Nancy, France, 54000
Olivet, France, 45160
Paris, France, 75 009
Paris, France, 75 017
Paris, France, 75007
Paris, France, 75018
Strasbourg, France, 67 000
Toulouse, France, 31000
Germany
Heidelberg, Baden-Württemberg, Germany, 69115
Frankfurt, Hessen, Germany, 60590
Wuppertal, Nordrhein-Westfalen, Germany, 42103
Blankenburg, Sachsen-Anhalt, Germany, 38889
Burg, Sachsen-Anhalt, Germany, 39288
Magdeburg, Sachsen-Anhalt, Germany, 39130
Gera, Thüringen, Germany, 07545
Kahla, Thüringen, Germany, 07768
Hamburg, Germany, 20357
Italy
Bologna, Italy, 40138
Brescia, Italy, 25123
Cagliari, Italy, 09124
Catania, Italy, 95123
Milano, Italy, 20154
Modena, Italy, 41124
Napoli, Italy, 80138
Palermo, Italy, 90127
Pavia, Italy, 27100
Pisa, Italy, 56126
Roma, Italy, 00189
Siena, Italy, 53100
Spain
Elda, Alicante, Spain, 03600
Boadilla del Monte, Madrid, Spain, 28660
Barcelona, Spain, 08019
Córdoba, Spain, 14004
Málaga, Spain, 29013
United Kingdom
Chesterfield, Derbyshire, United Kingdom, S40 4TF
Nottingham, Nottinghamshire, United Kingdom, NG2 4PJ
Bath, Somerset, United Kingdom, BA1 2SR
East Horsley, Surrey, United Kingdom, KT24 6QT
Bradford-on-Avon, Wiltshire, United Kingdom, BA15 1DQ
Corsham, Wiltshire, United Kingdom, SN3 9DL
Cardiff, United Kingdom, CF5 4AD
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01257984     History of Changes
Other Study ID Numbers: 14701
2010-019902-17 ( EudraCT Number )
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female