Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

Contraception Clinical Trial

Official title:

Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation of Two Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol and Either 1.05 or 2.1 mg Gestodene in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915915
• Other study ID #: 14348
• Secondary ID: 2009-009177-10
• Status: Completed
• Phase: Phase 2
• First received: May 18, 2009
• Last updated: October 27, 2014
• Start date: June 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• BMI: 18 BMI 30 kg/m²

• Healthy female volunteers

• Age 18-35 years (smoker not older than 30 years, inclusive)

• Ovulatory pre-treatment cycle, at least 3 month since delivery

• Abortion or lactation before the first screening examination

• Willingness to use non-hormonal methods of contraception during entire study

Exclusion Criteria:

• Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease

• Regular intake of medication other than OCs

• Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception
• Ovulation Inhibition

Intervention

Drug:
• Ethinylestradiol/Gestodene (BAY86-5016)
Transdermal patch: 0.55mg Ethinylestradiol (EE+2.1mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)
• Ethinylestradiol/Gestodene (BAY86-5016)
Transdermal patch: 0.55mg Ethinylestradiol (EE+1.05mg GSD)Gestodene; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles), 1 Follow - up cycle)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3		4 months	Yes
Secondary	The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3		4 months	Yes
Secondary	Course of gonadotropins (FSH, LH, P, E2)		4 months	Yes
Secondary	Endometrial thickness and Follicle size		4 months	Yes
Secondary	Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3		4 Months	Yes
Secondary	Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3		4 Months	Yes

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