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Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2

NCT01221831 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2012-09-14

No results posted yet for this study

Summary

This is an open-label, multi-centre, comparative study in young, healthy, female volunteers of reproductive age.

Primary objective:

\- To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal bleeding patterns (cycle control), in comparison with a combined oral contraceptive containing estradiol valerate and dienogest

Secondary objectives:

* To investigate ovulation inhibition
* To investigate the effect on SHBG
* To assess pregnancy rate
* To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight
* To investigate return of menstruation after treatment
* To evaluate general safety and acceptability

Conditions

  • Contraception

Interventions

DRUG

estetrol, P 1 and placebo tablets

6 treatment cycles each consisting of 28 days of oral administration as follows: * Days 1-24: one estetrol tablet and one P1 tablet per day * Days 25-28: two placebo tablets per day

DRUG

estetrol, P2 and placebo tablets

6 treatment cycles each consisting of 28 days of oral administration as follows: * Days 1-24: one estetrol tablet and one P2 tablet per day * Days 25-28: two placebo tablets per day

DRUG

Estradiol valerate, dienogest and placebo tablets

6 treatment cycles each consisting of 28 days of oral administration as follows: * Days 1-26: one tablet of Estradiol valerate/dienogest per day * Days 26-28: one placebo tablet per day

Sponsors & Collaborators

  • Estetra

    lead INDUSTRY

Principal Investigators

  • Dan Apter, M.D. · Väestöliitto Helsinki

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01221831 on ClinicalTrials.gov