Contraception
Conditions
Keywords
Contraception, Transdermal contraceptive patch, Safety, Efficacy, Pharmacokinetic
Brief summary
The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.
Interventions
7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female subjects requesting contraception * Aged 18 to 35 years (inclusive); smokers must not be older than 30 years * Normal or clinically insignificant cervical smear not requiring further follow-up * History of regular cyclic menstrual periods * Willingness to use nonhormonal methods of contraception during the entire study * Proven ovulation upon completion of the pretreatment cycle
Exclusion criteria
* Pregnancy or lactation * Obesity (body mass index \[BMI\] \> 30.0 kg/m2) * Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape * Any disease or condition that may worsen under hormonal treatment * Use of hormonal contraception other than study medication during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suppression of ovulatory activity proved by progesterone and estradiol concentrations | Treatment day 29 to day 84 | Estradiol levels \> 100pmol/L indicate some ovarian activity and progesterone levels \> 5nmol/L in subjects with estradiol levels \> 100pmol/L reflect ovulation or luteinized unruptured follicles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration, AUC (area under curve) of ethinyl estradiol | Multiple time points up to treatment day 84 | — |
| Serum concentration, AUC (area under curve) of Sexual hormone binding globulin | Multiple time points up to treatment day 84 | — |
| Number of patients with adverse events | Up to 84 days | — |
| Serum concentration, AUC (area under curve) of Gestodene | Multiple time points up to treatment day 84 | — |
| Time course of follicle-stimulating hormone | Day 27 of pretreatment cycle to treatment day 83 | Serum concentration of follicle-stimulating hormone (FSH) |
| Time course of luteinizing hormone | Day 27 of pretreatment cycle to treatment day 83 | Serum concentration of luteinizing hormone (LH) |
| Number of patients with abnormal safety laboratory | Up to 84 days | — |
Countries
Russia, Ukraine
Outcome results
None listed