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Dienogest

Generic Name
Dienogest
Brand Names
Natazia, Visanne
Drug Type
Small Molecule
Chemical Formula
C20H25NO2
CAS Number
65928-58-7
Unique Ingredient Identifier
46M3EV8HHE
Background

Dienogest is an orally-active semisynthetic progestogen which also possesses the properties of 17α-hydroxyprogesterone. It is a derivative of 19-nortestosterone and has antiandrogenic properties. It is primarily used as a contraceptive in combination with ethinylestradiol, or in other combination form pills approved in United States and Europe however it is not available in the US by itself. In Europe, Australia, Malaysia, Singapore and Japan, dienogest single therapy is an approved treatment for endometriosis to alleviate painful symptoms of endometriosis and reduce endometriotic lesions . Dienogest is commonly marketed as Visanne, Natazia and Qlaira.

Indication

Indicated for use as the treatment of endometriosis alone and as a contraceptive in combination with ethinylestradiol.

Associated Conditions
Hypermenorrhea, Pain
Associated Therapies
Contraception, Oral Contraceptives

Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery

Phase 4
Conditions
Endometriosis
Interventions
Drug: Microgynon
First Posted Date
2015-03-11
Last Posted Date
2015-04-29
Lead Sponsor
The University of Hong Kong
Target Recruit Count
144
Registration Number
NCT02385448
Locations
🇭🇰

Queen Mary Hospital, Hong Kong, Hong Kong

Synthetic vs Natural Estrogen in Combined Oral Contraception

First Posted Date
2015-02-02
Last Posted Date
2023-06-22
Lead Sponsor
Helsinki University Central Hospital
Target Recruit Count
59
Registration Number
NCT02352090
Locations
🇫🇮

Helsinki University Central Hospital, Kätilöopisto Maternity Hospital, Helsinki, Finland

🇫🇮

Oulu University Hospital, Department of Gynecology and Obstetrics, Oulu, Finland

Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients

Phase 3
Completed
Conditions
Endometriosis
Interventions
First Posted Date
2013-04-02
Last Posted Date
2015-11-25
Lead Sponsor
Bayer
Target Recruit Count
250
Registration Number
NCT01822080

Regulatory Post Marketing Surveillance Study in Korea

Completed
Conditions
Endometriosis
Interventions
First Posted Date
2013-02-11
Last Posted Date
2018-08-02
Lead Sponsor
Bayer
Target Recruit Count
3223
Registration Number
NCT01788722

Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin

Phase 4
Terminated
Conditions
Uterine Leiomyoma
Interventions
First Posted Date
2012-11-30
Last Posted Date
2020-08-13
Lead Sponsor
University of Sao Paulo
Target Recruit Count
14
Registration Number
NCT01738724

Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis

Phase 3
Completed
Conditions
Endometriosis
Interventions
Drug: EE20/DRSP(BAY86-5300)
Drug: Placebo
First Posted Date
2012-10-02
Last Posted Date
2016-02-18
Lead Sponsor
Bayer
Target Recruit Count
312
Registration Number
NCT01697111

Daily Practice Treatment and Influence of Visanne on the Patient Assessment of Quality of Life

Completed
Conditions
Endometriosis
Interventions
First Posted Date
2012-05-10
Last Posted Date
2015-07-10
Lead Sponsor
Bayer
Target Recruit Count
3006
Registration Number
NCT01595724

Visanne Study to Assess Safety in Adolescents

Phase 2
Completed
Conditions
Endometriosis
Interventions
First Posted Date
2011-01-26
Last Posted Date
2015-08-13
Lead Sponsor
Bayer
Target Recruit Count
111
Registration Number
NCT01283724

Pharmacodynamic Characterization of Dienogest

First Posted Date
2008-09-18
Last Posted Date
2015-01-27
Lead Sponsor
Bayer
Target Recruit Count
102
Registration Number
NCT00754871

Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

Phase 3
Completed
Conditions
Endometriosis
Interventions
First Posted Date
2005-09-23
Last Posted Date
2014-01-09
Lead Sponsor
Bayer
Target Recruit Count
168
Registration Number
NCT00225186
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