Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.

NCT01204190 | Completed Phase 2

• 2 other identifiers: 152642010-021255-81
• Study Type: interventional
• Target: 173
• Locations: 2 countries
• Sites: 2

Brief Summary

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals. With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.

Conditions

Contraception

Keywords

Administration; Cutaneous

Outcome Measures

Primary Outcomes (1)

• Hoogland score to evaluate the inhibition of ovulation

  After 2 months

Secondary Outcomes (3)

• Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone

  After 2 months

• Follicle size measured by transvaginal ultrasound examination

  After 2 months

• Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)

  After 2 months

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: Gestodene/EE Patch (BAY86-5016)

Arm 2

EXPERIMENTAL

Drug: Gestodene/EE Patch (BAY86-5016)

Arm 3

EXPERIMENTAL

Drug: Gestodene/EE Patch (BAY86-5016)

Interventions

Gestodene/EE Patch (BAY86-5016) DRUG

0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days

Arm 1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female volunteers
• age 18 - 35 years (smoker not older than 30 years, inclusive)
• ovulatory pre-treatment cycle

You may not qualify if:

• Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
• Regular intake of medication other than Oral Contraception
• Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

Berlin, State of Berlin, 10115, Germany

Location

Unknown Facility

Groningen, 9713 GZ, Netherlands

Location

Related Links

• Click here and search for information of Bayer products for Europe

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

DE (1); NL (1)