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A Double-Blind, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen / Progestogen Regimens in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles

This study is currently recruiting participants.
Verified by Bayer, February 2008

Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00631124
  Purpose

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
Healthy
Contraception
Drug: Estradiol / Drospirenone
Phase II

MedlinePlus related topics:   Birth Control   

ChemIDplus related topics:   Depogen    Estradiol    Estradiol 3-benzoate    Estradiol acetate    Estradiol cypionate    Estradiol dipropionate    Estradiol valerate    Polyestradiol phosphate    1,2-Dihydrospirorenone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of ovarian activity in treatment cycles 2 and 3 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Course of gonadotropins (FSH, LH) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Endometrial growth [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics of estrogen and progestin in treatment cycle 3 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   116
Study Start Date:   February 2008
Estimated Study Completion Date:   December 2008

Arms Assigned Interventions
Arm 1: Experimental
n/a
Drug: Estradiol / Drospirenone

Monophasic regimen containing estrogen and progestin

1 pre-treatment cycle, 3 treatment cycles

Arm 2: Experimental
n/a
Drug: Estradiol / Drospirenone

Triphasic regimen containing estrogen and progestin

1 pre-treatment cycle, 3 treatment cycles


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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631124

Contacts
Contact: Bayer Clinical Trials Contact     clinical-trials-contact@bayerhealthcare.com    

Locations
Germany
Bayer Clinical Research Center     Recruiting
      Berlin, Germany

Sponsors and Collaborators
Bayer

Investigators
Study Director:     Study Director Bayer Study Manager     Bayer    
  More Information

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Responsible Party:   ( Bayer Schering Pharma, Clinical Pharmacology, Therapeutic Area Head )
Study ID Numbers:   91697, EudraCT 2007-004544-73, 311623
First Received:   February 28, 2008
Last Updated:   March 6, 2008
ClinicalTrials.gov Identifier:   NCT00631124
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices;   United States: Food and Drug Administration

Keywords provided by Bayer:
Antibaby-Pille,  
Schwangerschaftsverhütung  

Study placed in the following topic categories:
Benzoates
Estradiol 3-benzoate
Estradiol valerate
Drospirenone
Estradiol 17 beta-cypionate
Healthy
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:
Estrogens
Aldosterone Antagonists
Contraceptive Agents
Hormone Antagonists
Therapeutic Uses
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008




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