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

NCT00280657 | Completed Phase 3

• 2 other identifiers: 91299307760
• Study Type: interventional
• Target: 1,326
• Locations: 5 countries
• Sites: 62

Brief Summary

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

Conditions

Acne Vulgaris

Keywords

Acne papulopustulosa

Outcome Measures

Primary Outcomes (1)

• Change in lesions

  6 months

Secondary Outcomes (2)

• ISGA

  6 months

• Parameters of safety and tolerability

  6 months

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: Valette

Arm 2

ACTIVE COMPARATOR

Drug: Diane

Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Valette DRUG

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

Arm 1

Diane DRUG

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

Arm 2

Placebo DRUG

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

Arm 3

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with mild to moderate facial papulopustular acne

You may not qualify if:

• Contraindication against use of hormonal contraceptives

Sponsors & Collaborators

• Bayer: lead

Study Sites (62)

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Chomutov, 43012, Czechia

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Čáslav, 28601, Czechia

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Kutná Hora, 28401, Czechia

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Louny, 44001, Czechia

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Olomouc, 77900, Czechia

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Prague, 10034, Czechia

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Prague, 15500, Czechia

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Slaný, 274 01, Czechia

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Svitavy, 56802, Czechia

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Ústí nad Labem, 40010, Czechia

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Grudziądz, 86-300, Poland

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Lodz, 90265, Poland

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Lublin, 20319, Poland

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Poznan, 60631, Poland

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Warsaw, 00710, Poland

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Warsaw, 01456, Poland

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Warsaw, 01684, Poland

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Warsaw, 02722, Poland

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Wroclaw, 50-353, Poland

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Korolyov, 141074, Russia

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Moscow, 109004, Russia

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Moscow, 121614, Russia

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Moscow, 123182, Russia

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Moscow, 123423, Russia

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Moscow, 125009, Russia

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Moscow, 125047, Russia

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Moskva, 107076, Russia

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Moskva, 121002, Russia

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Petrozavodsk, 185910, Russia

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Saint Petersburg, 190020, Russia

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Saint Petersburg, 192012, Russia

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Saint Petersburg, 192102, Russia

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Saint Petersburg, 194 291, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 194175, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 197183, Russia

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Saint Petersburg, 197198, Russia

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Banská Bystrica, 97401, Slovakia

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Bratislava, 83331, Slovakia

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Kosice-Saca, 04015, Slovakia

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Košice, 04066, Slovakia

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Nitra, 94901, Slovakia

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Alchevs'k, 94201, Ukraine

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Chernivtsi, 58000, Ukraine

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Dnipropetrovsk, 49076, Ukraine

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Donetsk, 83087, Ukraine

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Ivano-Frankivsk, 76000, Ukraine

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Kharkiv, 61057, Ukraine

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Kiev, 01032, Ukraine

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Kiev, 03035, Ukraine

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Kyiv, 01021, Ukraine

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Luhansk, 91017, Ukraine

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Lviv, 81130, Ukraine

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Makiivka, 86106, Ukraine

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Odesa, 65006, Ukraine

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Poltava, 314039, Ukraine

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Rivne, 33028, Ukraine

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Simferopol, 95006, Ukraine

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Ternopil, 46006, Ukraine

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Uzhhorod, 88011, Ukraine

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Zaporizhzhia, 69063, Ukraine

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MeSH Terms

Conditions

Acne Vulgaris

Interventions

Cyproterone

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2006
• First Posted: January 23, 2006
• Study Start: March 10, 2004
• Primary Completion: May 21, 2005
• Study Completion: May 21, 2005
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

SL (5); UA (19); PL (9); CZ (10); RU (19)