Objective of this study is the evaluation of contraceptive patches with EE and GSD. The inhibition of ovulation of three different patch formulations will be evaluated. Secondary objectives are the course of gonadotropins, estradiol and progesterone…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
contraception
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of subjects with ovulation in at least one of the treatment
cycles 2 and 3.
Secondary outcome
* course of FSH, LH, estradiol and progesterone levels
* follicle size
* pharmacokinetics of EE, GSD and SHBG in treatment cycle 2 and 3
Background summary
Transdermal drug application systems for hormones have been successfully used
in treatment of peri- and postmenopausal complaints for several years. The
hormones used can be applied to achieve contraception, but until now there is
only 1 patch available on the market. Because a patch has to be replaced only
once a week, compliance is improved compared to oral contraceptives.
Furthermore, the contraceptive efficacy is not reduced during vomiting and
diarrhoea. Blood levels of the applied hormones are more constant and show less
intra-individual variation than during use of an oral contraceptive.
In the present study, ovulation inhibition will be investigated following
application of three contraceptive patches with different contents of the
hormones ethinyl estradiol (EE) and gestodene (GSD).
Study objective
Objective of this study is the evaluation of contraceptive patches with EE and
GSD. The inhibition of ovulation of three different patch formulations will be
evaluated. Secondary objectives are the course of gonadotropins, estradiol and
progesterone levels as well as pharmacokinetic parameters.
Study design
A 3-arm design, open-label, randomized. 1 pre-treatment cycle, 3 treatment
cycles, 1 follow-up cycle. There will be stratification in 2 BMI groups (1
group with BMI between 18 and 30 kg/m2 and 1 group with BMI higher than 30
kg/m2).
Intervention
3 cycles use of patches in 3 different dosage groups. 21 days per treatment
cycle, i. e. 3x7 days patch wearing followed by a patch free interval of 7
days.
Study burden and risks
At screening: physical exam, gynecological exam including vaginal ultrasound,
cervical smear and venous puncture.
During treatment periods, there is a venous puncture and a vaginal ultrasound
in most visits.
Attachment and removal of patch will be checked.
Daily diary recording.
Use of additional non-hormonal contraception.
The risks of the study medication are similar to those of an oral
contraceptive.
Bayer Schering Pharma
D - 13353 Berlin
DE
Bayer Schering Pharma
D - 13353 Berlin
DE
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021255-81-NL |
| CCMO | NL33171.056.10 |
| Other | not yet available |