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Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa

NCT00280657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1326

Last updated 2023-06-06

No results posted yet for this study

Summary

The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Valette

1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles

DRUG

Diane

1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles

DRUG

Placebo

2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-10
Primary Completion
2005-05-21
Completion
2005-05-21

Countries

  • Czechia
  • Poland
  • Russia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00280657 on ClinicalTrials.gov