NCT00631124

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

8 months

First QC Date

February 28, 2008

Last Update Submit

November 28, 2014

Conditions

Contraception

Keywords

Contraception

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Assessment of ovarian activity in treatment cycles 2 and 3

    12 months

  • Course of gonadotropins (FSH, LH)

    12 months

  • Endometrial growth

    12 months

  • Pharmacokinetics of estrogen and progestin in treatment cycle 3

    12 months

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: BAY86-4891 (Estradiol / Drospirenone)

Arm 2

EXPERIMENTAL
Drug: BAY86-4891 (Estradiol / Drospirenone)

Interventions

BAY86-4891 (Estradiol / Drospirenone)DRUG

Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles

Arm 1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female volunteers,
  • Age 18 - 35 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Berlin, State of Berlin, 10115, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Related Links

MeSH Terms

Interventions

Estradioldrospirenone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

February 1, 2008

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

DE(2)