Clinical Trials

Trial Number	Title	Sponsor	Product		Product Aliases
CEN-301	A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin®) for the Treatment of Vasomotor Symptoms in Postmenopausal Women	Duramed Research, Inc	Cenestin® (synthetic conjugated estrogens, A) Tablets		Synthetic Conjugated Estrogens, A
ENJ-301	A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia 0.3mg) Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women	Duramed Research, Inc	Enjuvia™ (synthetic conjugated estrogens, B)		Synthetic Conjugated Estrogens, B SCE-B
GA326	A Randomized, Double-blind, Dose-ranging, Parallel-group Study to Compare the Safety and Efficacy of Synthetic 10-Component Conjugated Estrogens (SCE,B) (0.3, 0.625, and 1.25 mg modified release) with Placebo in Postmenopausal Women Suffering from Moderate to Severe Vasomotor Symptoms	Duramed Research, Inc	Enjuvia™ (synthetic conjugated estrogens, B)		Synthetic Conjugated Estrogens, B SCE-B
SEA-301	A Phase III, Parallel, Randomized, Multicenter, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Seasonale® Extended Oral Contraceptive Therapy - 84-Day Active Cycle	Duramed Research, Inc	Seasonale® (levonorgestrel-ethinyl estradiol) 0.15mg-0.03mg		None known
SEA-301A	A Phase IIIb, Parallel, Multicenter, Open-Label Clinical Study To Evaluate The Safety Of Seasonale® Extended Oral Contraceptive Therapy - 84-Day Active Cycle	Duramed Research, Inc	Seasonale® (levonorgestrel-ethinyl estradiol) 0.15mg-0.03mg		None known
PSE-301	A Phase III, Randomized, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Combination Oral Contraceptive Regimens Utilizing Ethinyl Estradiol During the Pill-Free Interval For Prevention of Pregnancy in Women.	Duramed Research, Inc	Seasonique® .(levonorgestrel-ethinyl estradiol tablets) 0.15mg-0.03mg and (ethinyl estradiol tablets) 0.01mg		DP3
PSE-302	A Phase III, Randomized, Multicenter, Clinical Trial to Evaluate the Efficacy For Prevention of Pregnancy in Women and Safety by Obtaining Endometrial Biopsies of a Combination Oral Contraceptive Regimen Utilizing Ethinyl Estradiol During the Pill-Free Interval.	Duramed Research, Inc	Seasonique® .(levonorgestrel-ethinyl estradiol tablets) 0.15mg-0.03mg and (ethinyl estradiol tablets) 0.01mg		DP3
PSE-310	A Prospective, Single-Center, Open-Label Randomized Study to Evaluate the Suppression of the Pituitary-Ovarian Axis with Three Different Regimens of Oral Contraceptive Pills	Duramed Research, Inc	Seasonique® - (levonorgestrel-ethinyl estradiol tablets) 0.15mg-0.03mg and (ethinyl estradiol tablets) 0.01mg		DP3