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Ovulation Inhibition of Two 4-Phasic Oral Contraceptive Regimens
This study has been completed.
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00805415
  Purpose

The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens


Condition Intervention Phase
Ovulation Inhibition
 Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
Drug: EV/DNG (SH T00658L)
 Phase II

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Dienogest Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Multicenter, Open-Label, Randomized, Comparative Study to Evaluate Ovulation Inhibition With Two 4-Phasic Oral Contraceptive Regimens Containing Estradiol Valerate and Dienogest Applied Daily for Three Cycles to 200 Healthy Female Volunteer

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation) [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation) [ Time Frame: Treatment cycles 2 or 3 ] [ Designated as safety issue: No ]
  • Measurements of endometrial thickness [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
  • Visibility of cervical mucus [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
  • Ovarian activity (Hoogland score) [ Time Frame: Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
  • Measurements of follicle size [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
  • Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol) [ Time Frame: Treatment cycles 2 and 3 ] [ Designated as safety issue: No ]
  • Compliance [ Time Frame: Throughout whole study ] [ Designated as safety issue: No ]
  • Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signs [ Time Frame: Various timepoint throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: March 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg
Arm 2: Experimental Drug: EV/DNG (SH T00658L)
Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

  Eligibility

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

Inclusion Criteria:

  • Healthy women willing to use non-hormonal methods of contraception

Exclusion Criteria:

  • Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805415

Locations
Germany
Berlin, Germany, 13342
Netherlands
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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No publications provided

Responsible Party: Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers: 91271, 307300
Study First Received: December 8, 2008
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00805415  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   United States: Food and Drug Administration

Keywords provided by Bayer:
Oral Contraceptive
Ovulation Inhibition

Study placed in the following topic categories:
Benzoates
Estradiol 3-benzoate
Estradiol valerate
Estradiol 17 beta-cypionate
 Healthy
Polyestradiol phosphate
Estradiol
Dienogest

Additional relevant MeSH terms:
Estrogens
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptive Agents, Female
 Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009



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