- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204190
Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.
Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Berlin, Germany, 10115
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Groningen, Netherlands, 9713 GZ
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy female volunteers
- age 18 - 35 years (smoker not older than 30 years, inclusive)
- ovulatory pre-treatment cycle
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
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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
0.35 mg ethinyl estradiol (EE) + 0.67 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
0.275 mg ethiny estradiol (EE) + 1.05 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
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Experimental: Arm 2
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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
0.35 mg ethinyl estradiol (EE) + 0.67 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
0.275 mg ethiny estradiol (EE) + 1.05 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
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Experimental: Arm 3
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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
0.35 mg ethinyl estradiol (EE) + 0.67 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
0.275 mg ethiny estradiol (EE) + 1.05 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hoogland score to evaluate the inhibition of ovulation
Time Frame: After 2 months
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After 2 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone
Time Frame: After 2 months
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After 2 months
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Follicle size measured by transvaginal ultrasound examination
Time Frame: After 2 months
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After 2 months
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Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)
Time Frame: After 2 months
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After 2 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- 15264
- 2010-021255-81 (EudraCT Number)
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