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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00471991
First received: May 9, 2007
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Oral Contraceptive
Drug: SH T04769G
Drug: Ethinyl estradiol / dienogest (SH D00659 AF)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Follicle size (leading follicle) by transvaginal ultrasonography [ 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 ] [ Designated as safety issue: No ]
  • Endogenous hormones (estradiol, progesterone, FSH, LH) [ 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 ] [ Designated as safety issue: No ]
  • Assessment of cervical mucus according to Insler [ 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetic evaluation in volunteers who receive SH T04769G [ 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: SH T04769G
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.
Experimental: Arm 2 Drug: Ethinyl estradiol / dienogest (SH D00659 AF)
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female volunteers, aged 18 - 35 years (smokers up to 30 years)
  • Willingness to apply non-hormonal methods of contraception during the course of the study (e.g., condom with spermicide, diaphragm with spermicide)
  • Confirmation of ovulation during the cycle before treatment
  • Normal routine blood values

Exclusion Criteria:

  • Contraindications for the use of oral contraceptives
  • Pregnancy, lactation
  • Simultaneous participation in another clinical study
  • Considerable overweight
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471991

Locations
Germany
Berlin, Germany, 10115
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00471991     History of Changes
Other Study ID Numbers: 91539, 2006-006633-41, 310723
Study First Received: May 9, 2007
Last Updated: January 23, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Oral contraceptive
ovulation inhibitory effect

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Dienogest
Ethinyl Estradiol
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Contraceptive Agents, Male
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014