NCT00673686

Brief Summary

In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on "contraceptive robustness" of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

May 6, 2008

Last Update Submit

October 10, 2014

Conditions

Contraceptives, Oral

Keywords

Oral contraceptiveOvulationMissing pillsIntake complianceCycle control

Outcome Measures

Primary Outcomes (1)

  • Hoogland scores in cycles 2 and 3

    Treatment cycles 2 and 3 (treatment weeks 5-12)

Secondary Outcomes (4)

  • Follicle size

    Treatment cycles 2 and 3 (treatment weeks 5-12

  • Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone

    Treatment cycles 2 and 3 (treatment weeks 5-12

  • Endometrial thickness

    Treatment cycles 2 and 3 (treatment weeks 5-12

  • Cervical mucus

    Treatment cycles 2 and 3 (treatment weeks 5-12

Study Arms (2)

Arm 2

ACTIVE COMPARATOR
Drug: Yasminelle (SH T 00186 D)

Arm 1

EXPERIMENTAL
Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

Interventions

YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)DRUG

SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each

Arm 1
Yasminelle (SH T 00186 D)DRUG

SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Healthy women aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive)
  • No contraindications for combined oral contraceptive (COC) use

You may not qualify if:

  • Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) \> 30,
  • Known hypersensitivity to any of the study drug ingredients
  • Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study, or the interpretation of the results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

  • Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.

    PMID: 21721590RESULT

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combinationdrospirenone

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 7, 2008

Study Start

May 1, 2004

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

October 13, 2014

Record last verified: 2014-10

Locations

NL(1)