Clinical trial NCT01257984: Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-12-10
Enrollment: 508
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time
timeFrame: 12 months
Secondary outcomes:
measure: Number of delayed and missed pills
timeFrame: 12 months
measure: Bleeding pattern and cycle control parameters
timeFrame: 12 months
measure: Length of the tablet break and the length of the bleeding episode preceding the tablet break
timeFrame: 12 months
Other outcomes:
Locations:
city: Biarritz
country: France
city: Marly Le Roi
country: France
city: Nancy
country: France
city: Olivet
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Frankfurt
country: Germany
state: Hessen
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Blankenburg
country: Germany
state: Sachsen-Anhalt
city: Burg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Gera
country: Germany
state: Thüringen
city: Kahla
country: Germany
state: Thüringen
city: Hamburg
country: Germany
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Cagliari
country: Italy
city: Catania
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Napoli
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Elda
country: Spain
state: Alicante
city: Boadilla del Monte
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Málaga
country: Spain
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Nottingham
country: United Kingdom
state: Nottinghamshire
city: Bath
country: United Kingdom
state: Somerset
city: East Horsley
country: United Kingdom
state: Surrey
city: Bradford-on-Avon
country: United Kingdom
state: Wiltshire
city: Corsham
country: United Kingdom
state: Wiltshire
city: Cardiff
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: