Trial Condition(s):

Acne vulgaris

Study on safety and efficacy of an oral contraceptive in treating acne papulopustulosa

Bayer Identifier:

91299

ClinicalTrials.gov Identifier:

NCT00280657

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

Inclusion Criteria

- Patients with mild to moderate facial papulopustular acne

Exclusion Criteria

- Contraindication against use of hormonal contraceptives

Trial Summary

Enrollment Goal

1326

Trial Dates

March2004

May2005

Phase

Could I receive a placebo?

Yes

Products

Valette (Dienogest/EE30, BAY86-5038)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Investigative Site Usti nad Labem, Czech Republic, 40010	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Praha, Czech Republic, 10034	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Chomutov, Czech Republic, 43012	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Lublin, Poland, 20319	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Lodz, Poland, 90265	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Poznan, Poland, 60631	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Warszawa, Poland, 02722	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Grudziadz, Poland, 86-300	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site St. Petersburg, Russia, 197183	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Sankt-Peterburg, Russia, 195067	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Moscow, Russia, 123423	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Moscow, Russia, 125009	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Moskva, Russia, 107076	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site St. Petersburg, Russia, 190020	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Moscow, Russia, 121614	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site St. Petersburg, Russia, 194044	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Moscow, Russia, 125047	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Moscow, Russia, 123182	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kosice-Saca, Slovakia, 04015	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Bratislava, Slovakia, 83331	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Dnipropetrovsk, Ukraine, 49076	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kiev, Ukraine, 01032	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Alchevsk, Ukraine, 94201	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kiev, Ukraine, 03035	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Ternopil, Ukraine, 46006	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Odessa, Ukraine, 65006	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kharkiv, Ukraine, 61057	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Donetsk, Ukraine, 83087	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Makeevka, Ukraine, 86106	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Caslav, Czech Republic, 28601	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kutna Hora, Czech Republic, 28401	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Olomouc, Czech Republic, 77900	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Slany, Czech Republic, 274 01	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Svitavy, Czech Republic, 56802	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Praha, Czech Republic, 15500	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Louny, Czech Republic, 44001	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Warszawa, Poland, 00710	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Warszawa, Poland, 01684	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Warszawa, Poland, 01456	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Wroclaw, Poland, 50-353	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site St. Petersburg, Russia, 197198	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Petrozavodsk, Russia, 185910	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Moscow, Russia, 109004	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Lviv, Ukraine, 81130	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Sankt-Peterburg, Russia, 194 291	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site St. Petersburg, Russia, 192012	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Moskva, Russia, 121002	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Korolev, Russia, 141074	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site St. Petersburg, Russia, 192102	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site St. Petersburg, Russia, 194175	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kosice, Slovakia, 04066	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Banska Bystrica, Slovakia, 97401	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Nitra, Slovakia, 94901	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Uzhhorod, Ukraine, 88011	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Ivano-Frankivsk, Ukraine, 76000	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Chernivtsi, Ukraine, 58000	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Poltava, Ukraine, 314039	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kyiv, Ukraine, 01021	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Zaporizhzhia, Ukraine, 69063	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Rovno, Ukraine, 33000	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Simferopol, Ukraine, 95006	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Lugansk, Ukraine, 91017	Status Active, not recruiting	Contact Us: E-mail: [email protected] Phone: Not Available

Trial Design

Multicenter, double-blind, double-dummy, randomized parallel group study to evaluate the safety and efficacy of SH D 00659 E for 6 treatment cycles in female patients with acne papulopustulosa in comparison to SH D 00659 G and placebo.

Trial Type:

Interventional

Intervention Type:

Drug

Trial Purpose:

Treatment

Allocation:

Randomized

Blinding:

Double Blind

Assignment:

Parallel Assignment

Trial Arms:

Primary Outcome

Change in lesions
Timeframe: 6 months

Secondary Outcome

ISGA
Timeframe: 6 months

Parameters of safety and tolerability
Timeframe: 6 months

Acne vulgaris

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

16 Years

45 Years

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information