Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites

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

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

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Gestodene/EE Patch (BAY86-5016); Drug: Gestodene/EE Patch (BAY86-5016); Drug: Gestodene/EE Patch (BAY86-5016)

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1	Drug: Gestodene/EE Patch (BAY86-5016); Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks; Drug: Gestodene/EE Patch (BAY86-5016); Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm; Drug: Gestodene/EE Patch (BAY86-5016); Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen
EXPERIMENTAL: Arm 2	Drug: Gestodene/EE Patch (BAY86-5016); Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks; Drug: Gestodene/EE Patch (BAY86-5016); Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm; Drug: Gestodene/EE Patch (BAY86-5016); Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen
EXPERIMENTAL: Arm 3	Drug: Gestodene/EE Patch (BAY86-5016); Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks; Drug: Gestodene/EE Patch (BAY86-5016); Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm; Drug: Gestodene/EE Patch (BAY86-5016); Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC(0-168) for EE and Gestodene during week 4 of each treatment period	Week 4 of each treatment period ( 3 periods)

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week	Week 1-5 of each treatment period
Adverse Events	Week 1-5 of each treatment period

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: March 8, 2010
• First Posted (ESTIMATE): March 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 23, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacokinetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Gestodene
• Other Study ID Numbers: 91608; 2009-011151-52 (EUDRACT_NUMBER)