Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00805415
First received: December 8, 2008
Last updated: July 14, 2011
Last verified: July 2011
  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
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

  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
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: 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:
No publications provided

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
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 23, 2014