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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631124
• Other study ID #: 91697
• Secondary ID: 2007-004544-7331
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2008
• Last updated: November 28, 2014
• Start date: February 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• BAY86-4891 (Estradiol / Drospirenone)
Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
• BAY86-4891 (Estradiol / Drospirenone)
Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 months	No
Secondary	Assessment of ovarian activity in treatment cycles 2 and 3		12 months	No
Secondary	Course of gonadotropins (FSH, LH)		12 months	No
Secondary	Endometrial growth		12 months	No
Secondary	Pharmacokinetics of estrogen and progestin in treatment cycle 3		12 months	No

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