NCT00805415

Brief Summary

The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2

Geographic Reach
2 countries

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

March 1, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
Last Updated

July 15, 2011

Status Verified

July 1, 2011

Enrollment Period

11 months

First QC Date

December 8, 2008

Last Update Submit

July 14, 2011

Conditions

Ovulation Inhibition

Keywords

Oral ContraceptiveOvulation Inhibition

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)

    Treatment cycles 2 and 3

Secondary Outcomes (8)

  • Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)

    Treatment cycles 2 or 3

  • Measurements of endometrial thickness

    Treatment cycles 2 and 3

  • Visibility of cervical mucus

    Treatment cycles 2 and 3

  • Ovarian activity (Hoogland score)

    Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3

  • Measurements of follicle size

    Treatment cycles 2 and 3

  • +3 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Arm 2

EXPERIMENTAL
Drug: EV/DNG (SH T00658L)

Interventions

EV/DNG (Qlaira, BAY86-5027, SH T00658K)DRUG

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg

Arm 1
EV/DNG (SH T00658L)DRUG

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Healthy women willing to use non-hormonal methods of contraception

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dinox GmbH Berlin

Berlin, State of Berlin, 10115, Germany

Location

Dinox B.V.

Groningen, 9713 GZ, Netherlands

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 9, 2008

Study Start

March 1, 2003

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

July 15, 2011

Record last verified: 2011-07

Locations

NL(1)DE(1)