Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers
Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
transdermal patch: 0.55mg EE+2.1mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles)
transdermal patch: 0.55mg EE+1.05 mg GSD; 3x7 days patch- wearing phase and a patch-free interval of 7 days (1 pre-treatment cycle, 3 treatment cycles
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
Unnamed facility
Berlin, State of Berlin, Germany
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3.
Time frame: 4 month
Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score)
Time frame: 4 month
Course of gonadotropins (FSH, LH, P, E2)
Time frame: 4 month
Endometrial thickness
Time frame: 4 month
Follicle size
Time frame: 4 month
Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3
Time frame: 4 month
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