NCT00471991

Monocenter, Open-label, Randomized Study to Determine the Ovulation Inhibitory Effect of the Combined Oral Contraceptive SH T04769G and SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest), Applied for Two Treatment Cycles to 60 Healthy Female Volunteers

Completed Phase 2 Last updated 23 January 2013

What this trial tests

Phase 2 trial testing SH T04769G in Oral Contraceptive in 60 participants. Completed in 1 December 2007.

Timeline

1 April 2007

Primary endpoint
1 December 2007

1 December 2007

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 April 2007
Primary completion	1 December 2007
Estimated completion	1 December 2007
Sites	1 location across Germany

Drugs / interventions tested

• SH T04769G — full drug profile →
• Ethinyl estradiol / dienogest (SH D00659 AF) — full drug profile →

Conditions studied

• Oral Contraceptive — all drugs for Oral Contraceptive →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 35, female only, with Oral Contraceptive. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The primary efficacy variable is ovulation inhibition in Cycle 2 (yes/no). Ovarian activity will be classified according to Hoogland and Skouby (1993).
  Time frame: 4 cycles: one cycle before treatment followed by two treatment cycles (28 days each, 21 days with tablet intake followed by a 7-day tablet-free interval) one post-treatment cycle

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.