Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.
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.
Timeline
- Start
- 2010-09
- Primary completion
- 2011-07
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gestodene | Small molecule | 0.67 mg | Other |
| Subject | Gestodene | Small molecule | 1.05 mg | Other |
| Subject | Gestodene | Small molecule | 2.1 mg | Other |
| Subject | ethinyl estradiol | Small molecule | 0.275 mg | Other |
| Subject | ethinyl estradiol | Small molecule | 0.35 mg | Other |
| Subject | ethinyl estradiol | Small molecule | 0.55 mg | Other |
Indications
No indication recorded.