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CLINICAL TRIALS PROFILE FOR DROSPIRENONE AND ETHINYL ESTRADIOL

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Clinical Trials for Drospirenone And Ethinyl Estradiol

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00413062	Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)	Completed	Merck Sharp & Dohme Corp.	Phase 3	The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
NCT00511199	Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)	Completed	Merck Sharp & Dohme Corp.	Phase 3	The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
NCT00511433	Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)	Completed	Merck Sharp & Dohme Corp.	Phase 3	The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
NCT00567164	Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ	Completed	Bayer	Phase 3	The purpose of this study is to determine whether the study drug is safe and effective.
NCT00633360	The Oral Contraceptive Pill for Premenstrual Worsening of Depression	Completed	Massachusetts General Hospital	N/A	To determine if augmentation with the oral-contraceptive pill containing drospirenone and ethinyl estradiol is more effective than placebo in the treatment of premenstrual breakthrough of depression.
NCT00640224	Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).

Clinical Trial Conditions for Drospirenone And Ethinyl Estradiol

Condition Name

Condition Name for Drospirenone And Ethinyl Estradiol
Intervention	Trials
Contraception	10
Polycystic Ovary Syndrome	4
Healthy	4
Acne Vulgaris	3

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Condition MeSH

Condition MeSH for Drospirenone And Ethinyl Estradiol
Intervention	Trials
Polycystic Ovary Syndrome	4
Acne Vulgaris	3
Syndrome	3
Dysmenorrhea	2

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Clinical Trial Locations for Drospirenone And Ethinyl Estradiol

Trials by Country

Trials by Country for Drospirenone And Ethinyl Estradiol
Location	Trials
United States	82
China	19
Germany	14
United Kingdom	6
Austria	4

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Trials by US State

Trials by US State for Drospirenone And Ethinyl Estradiol
Location	Trials
California	5
Massachusetts	5
Pennsylvania	5
Florida	4
Arizona	4

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Clinical Trial Progress for Drospirenone And Ethinyl Estradiol

Clinical Trial Phase

Clinical Trial Phase for Drospirenone And Ethinyl Estradiol
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	15
Phase 2	1

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Clinical Trial Status

Clinical Trial Status for Drospirenone And Ethinyl Estradiol
Clinical Trial Phase	Trials
Completed	20
Not yet recruiting	3
Terminated	2

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Clinical Trial Sponsors for Drospirenone And Ethinyl Estradiol

Sponsor Name

Sponsor Name for Drospirenone And Ethinyl Estradiol
Sponsor	Trials
Bayer	12
Massachusetts General Hospital	3
Merck Sharp & Dohme Corp.	3

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Sponsor Type

Sponsor Type for Drospirenone And Ethinyl Estradiol
Sponsor	Trials
Industry	22
Other	11
NIH	1

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