Valette (Combined Oral Contraceptive SH T04769G and SH D00659AF) Low Ovulation Inhibition

The study consists of 4 cycles resulting in approx. 16 weeks of study participation. The investigational product is an oral contraceptive. 21 tablets are taken each cycle followed by a 7-day tablet-free interval. (One cycle lasts for 28 days.)Volunteers will have to come for a visit every 2 to 4 days over the whole study period.The function of the ovaries is studied by transvaginal ultrasonography and determination of hormonal parameters from blood samples. The mouth of the uterus is inspected during each visit and the cervical smear will be investigated. Adverse events will be recorded and diary entries will be controlled by the investigator.

The study consists of 4 cycles resulting in approx. 16 weeks of study participation. The investigational product is an oral contraceptive. 21 tablets are taken each cycle followed by a 7-day tablet-free interval. (One cycle lasts for 28 days.)Volunteers will have to come for a visit every 2 to 4 days over the whole study period.The function of the ovaries is studied by transvaginal ultrasonography and determination of hormonal parameters from blood samples. The mouth of the uterus is inspected during each visit and the cervical smear will be investigated. Adverse events will be recorded and diary entries will be controlled by the investigator.Volunteers have to undergo a series of blood sampling during the 2nd treatment cycle to evaluate the pharmacokinetic (liberation, absorption, distribution, metabolization and excretion) of the new oral contraceptive.