Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00729404
• Other study ID #: 91558
• Secondary ID: 2008-001198-13
• Status: Terminated
• Phase: Phase 2
• First received: August 4, 2008
• Last updated: November 27, 2014
• Start date: August 2008
• Est. completion date: February 2009

Study information

• Verified date: November 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

Description:

Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Signed informed consent,

• BMI: 18 - 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/arterial 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 EE+2.1mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles)
• Ethinylestradiol/Gestodene (BAY86-5016)
transdermal patch: 0.55mg EE+1.05 mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles

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 month	Yes
Secondary	Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score)		4 month	Yes
Secondary	Course of gonadotropins (FSH, LH, P, E2)		4 month	Yes
Secondary	Endometrial thickness		4 month	Yes
Secondary	Follicle size		4 month	Yes
Secondary	Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3		4 month	Yes

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