Valette (Combined Oral Contraceptive SH T04769G and SH D00659AF) Low Ovulation Inhibition
Condition: Oral Contraceptive
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this monocenter, open-label, randomized study is to determine the ovulation
      inhibitory effect of the combined oral contraceptive (COC) SH T04769G and to collect
      supplementary data regarding the ovulation inhibitory effect of the COC Valette® SH D00659AF
      (0.03 mg EE and 2.0 mg DNG), each applied for two treatment cycles in 60 healthy female
      volunteers, aged 18-35 years.Combined oral contraceptives consist of two components: an
      estrogen and a progestin. The estrogen is required for a regular cycle; the progestin ensures
      the protection against unwanted pregnancy. In a sufficient dosage, progestins prevent
      ovulation. The investigational product is an oral contraceptive that contains the estrogen
      ethinylestradiol and the progestin dienogest as active ingredients. 21 tablets are taken each
      cycle followed by a 7-day tablet-free interval. Thus, the whole cycle lasts for 28 days.The
      marketed oral contraceptive Valette® contains both ingredients (ethinylestradiol and
      dienogest) in a higher dose. One half of the volunteers (30 volunteers) will receive this
      product. Efficacy and safety were already confirmed by numerous clinical studies.Another 30
      volunteers will receive the investigational product. The dose reduction is not assumed to
      have a negative impact on tolerance.The study is aimed to show whether the reduced dosage is
      sufficient for contraception.Course of the study:The study consists of 4 cycles (one cycle
      before treatment, followed by two treatment cycles and one post-treatment cycle) resulting in
      approx. 16 weeks of study participation. The post-treatment cycle is aimed to observe the
      return to the normal function of the ovaries. Volunteers will have to come for a visit every
      2 to 4 days over the whole study period.Visit 1The investigator will explain the study in
      detail and the volunteer will be given ample time and opportunity to ask questions. If all
      questions were answered the volunteer will decide on participation in the study. If she
      decides to take part, she will give her written consent on the Informed Consent
      Form.Afterwards, a pregnancy test will be performed, a complete medical, surgical and
      medication history will be recorded and physical and gynaecological examinations will be
      performed. Transvaginal ultrasonography will be done and smear from the mouth of the uterus
      is taken for precaution of cancer.Blood (10 ml) will be drawn to determine routine safety
      lab, heart rate and blood pressure will be measured and height and weight will be
      recorded.Volunteers will be provided with a diary that has to be filled in on a daily basis
      during the whole study period (bleeding records, intake of study medication, performance of
      pregnancy tests).During the whole study non-hormonal methods of contraception have to be used
      (condom plus spermicide; diaphragm with spermicide). During the cycle before study treatment,
      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. Visits will be performed every 4 days.If
      ovulation can be confirmed, volunteers will be randomized to one of the treatment
      groups.Volunteers who will receive the investigational product will undergo a blood sampling
      on a given day of this cycle to determine the baseline hormonal status (fasting condition).A
      home pregnancy test has to be done by the volunteer before intake of the study medication.
      Only in case a pregnancy is excluded, intake of study medication will start.Treatment
      cycles:During these cycles, visits are performed every 3 days to determine ovarian activity
      (transvaginal ultrasonography, blood sampling, inspection of the mouth of the uterus and
      cervical smear investigation). Adverse events will be recorded and diary entries will be
      controlled by the investigator.Volunteers who receive the investigational product 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.Post-treatment cycle:Non-hormonal contraceptive methods have also to
      be used during the post-treatment cycle. It starts immediately after the 2nd treatment cycle,
      i.e., on the 8th day after the last tablet intake and ends with the start of the next
      menstrual bleeding. Visits will be performed every 4 days to determine the return of ovarian
      activity by transvaginal ultrasound measures and blood sampling for hormone determination.
      After end of the next menstrual bleeding, a final Visit including physical and gynaecological
      examinations will be performed. Options for further contraceptive methods will be discussed
      with the investigator.
    

Detailed description: 
      The trial is sponsored by Bayer Schering Pharma AG, Germany.
    

Intervention name(s): SH T04769G; Ethinyl estradiol / dienogest (SH D00659 AF)
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Dienogest; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral contraceptive; ovulation inhibitory effect