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A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: February 28, 2008
Last updated: November 28, 2014
Last verified: November 2014
Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles

Condition Intervention Phase
Contraception Drug: BAY86-4891 (Estradiol / Drospirenone) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Oral Estradiol / Drospirenone Regimens in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Assessment of ovarian activity in treatment cycles 2 and 3 [ Time Frame: 12 months ]
  • Course of gonadotropins (FSH, LH) [ Time Frame: 12 months ]
  • Endometrial growth [ Time Frame: 12 months ]
  • Pharmacokinetics of estrogen and progestin in treatment cycle 3 [ Time Frame: 12 months ]

Enrollment: 103
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY86-4891 (Estradiol / Drospirenone)
Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
Experimental: Arm 2 Drug: BAY86-4891 (Estradiol / Drospirenone)
Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy female volunteers,
  • Age 18 - 35 years

Exclusion Criteria:

  • Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease)
  • Regular intake of medication
  • Clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
  • Anovulatory pre-treatment cycle
  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 identifier: NCT00631124

Berlin, Germany, 10115
Berlin, Germany, 13353
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00631124     History of Changes
Other Study ID Numbers: 91697
2007-004544-73 ( EudraCT Number )
311623 ( Other Identifier: Company internal )
Study First Received: February 28, 2008
Last Updated: November 28, 2014

Keywords provided by Bayer:

Additional relevant MeSH terms:
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on September 21, 2017