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Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

This study has been completed.
Information provided by:
Bayer 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
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

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 ]

Secondary Outcome Measures:
  • Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation) [ Time Frame: Treatment cycles 2 or 3 ]
  • Measurements of endometrial thickness [ Time Frame: Treatment cycles 2 and 3 ]
  • Visibility of cervical mucus [ Time Frame: Treatment cycles 2 and 3 ]
  • Ovarian activity (Hoogland score) [ Time Frame: Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3 ]
  • Measurements of follicle size [ Time Frame: Treatment cycles 2 and 3 ]
  • Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol) [ Time Frame: Treatment cycles 2 and 3 ]
  • Compliance [ Time Frame: Throughout whole study ]
  • 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 ]

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   (Adult)
Sexes 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
  Contacts and Locations
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Please refer to this study by its 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 Identifier: NCT00805415     History of Changes
Other Study ID Numbers: 91271
Study First Received: December 8, 2008
Last Updated: July 14, 2011

Keywords provided by Bayer:
Oral Contraceptive
Ovulation Inhibition

Additional relevant MeSH terms:
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents
Polyestradiol phosphate
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Contraceptive Agents, Male
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on May 25, 2017