Study Completed

Contraception

Bayer Identifier:

91608

ClinicalTrials.gov Identifier:

NCT01083264

EudraCT Number:

2009-011151-52

EU CT Number:

Not Available

Relative bioavailability, transdermally administered EE and GSD, 3 applications sites

Trial purpose

Influence of different application sites on the blood levels after administration of a fertility control patch

Key Participants Requirements

Sex

Female

Age

18 - 45 Years

Inclusion Criteria
- Healthy female subjects
- Age 18-45 years
- Body mass index (BMI) 18-30kg/m²
- At least 3 months since delivery, abortion, or lactation before the first screening examination
- Ability to understand and follow study-related instructions
- Willingness to accept the synchronizing cycle and to use non-hormonal methods of contraception after starting the synchronizing cycle and during the treatment periods
Exclusion Criteria
- Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine)
- Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance
- Regular use of medicines other than contraceptives
- Smokers (at the age of 31 to 45 years)
- Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)

Trial summary

Enrollment Goal

Trial Dates

October 2009 - May 2010

Phase

Phase 1

Could I Receive a placebo

Products

Gestodene/EE Patch (BAY86-5016)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Bayer Pharma AG	Berlin, 13353, Germany

Primary Outcome

AUC(0-168) for EE and Gestodene during week 4 of each treatment period
Time Frame:
Week 4 of each treatment period ( 3 periods)
Safety Issue:
no

Secondary Outcome

Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week
Time Frame:
Week 1-5 of each treatment period
Safety Issue:
no
Adverse Events
Time Frame:
Week 1-5 of each treatment period
Safety Issue:
yes

Trial design

Open-label, randomized, crossover study to investigate the relative bioavailability of transdermally administered ethinylestradiol (EE) and gestodene (GSD) after repeated applications of a fertility control patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene to 3 different application sites (buttocks, arm versus abdomen) in healthy young female subjects

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.