Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: December 8, 2008
Last updated: July 14, 2011
Last verified: July 2011
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 2

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

Resource links provided by NLM:

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: 209
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
Experimental: Arm 1 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
Experimental: Arm 2 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


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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00805415

Dinox GmbH Berlin
Berlin, Germany, 10115
Dinox B.V.
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00805415     History of Changes
Other Study ID Numbers: 91271  307300 
Study First Received: December 8, 2008
Last Updated: July 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bayer:
Oral Contraceptive
Ovulation Inhibition

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 26, 2016