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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01257984
First received: December 9, 2010
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Contraception
Drug: BAY86-5300
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of delayed and missed pills [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Bleeding pattern and cycle control parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Length of the tablet break and the length of the bleeding episode preceding the tablet break [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 508
Study Start Date: December 2010
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257984

  Show 43 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01257984     History of Changes
Other Study ID Numbers: 14701, 2010-019902-17
Study First Received: December 9, 2010
Last Updated: September 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on April 15, 2014