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Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00805415
First Posted: December 9, 2008
Last Update Posted: July 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805415


Locations
Germany
Dinox GmbH Berlin
Berlin, Germany, 10115
Netherlands
Dinox B.V.
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Bayer
Investigators
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
First Submitted: December 8, 2008
First Posted: December 9, 2008
Last Update Posted: July 15, 2011
Last Verified: July 2011

Keywords provided by Bayer:
Oral Contraceptive
Ovulation Inhibition

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