23 completed, 2 withdrawn. 14 Phase 3, 9 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 14 | Completed 13, Withdrawn 1 |
| Phase 2 | 9 | Completed 9 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females 91-day Levonorgestrel Oral Contraceptive, 28-day Levonorgestrel Oral Contraceptive - Bone Mineral Density | Phase 2 | Completed | Duramed Research | 1361 | 2009-06-01 | 2014-10-22 |
| A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches 91-day Levonorgestrel Oral Contraceptive, Placebo - Migraine | Phase 2 | Completed | Duramed Research | 109 | 2009-01-01 | 2017-02-06 |
| Emergency Contraception Actual Use Study DR-104 - Emergency Contraception | Phase 3 | Completed | Duramed Research | 343 | 2008-10-01 | 2012-10-18 |
| A Safety Extension Study of DR-OXY-301 Oxybutinyn Vaginal Ring 4mg, Oxybutinyn Vaginal Ring 6mg - Overactive Bladder | Phase 3 | Completed | Duramed Research | 240 | 2008-09-01 | 2023-03-16 |
| Intrauterine Device (IUD) Placement at the Time of Cesarean Section Intrauterine Device Placement | Withdrawn | University of Kentucky | 2008-08-01 | 2016-12-22 | ||
| A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder DR-3001, Placebo - Overactive Bladder | Phase 3 | Completed | Duramed Research | 1104 | 2008-05-01 | 2016-07-20 |
| A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization DR-2011, Crinone 8% - Infertility | Phase 3 | Completed | Duramed Research | 1297 | 2008-02-01 | 2013-09-13 |
| Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women SCE-B, Placebo - Nocturnal Vasomotor Symptoms | Phase 4 | Completed | Duramed Research | 157 | 2007-12-01 | 2013-07-19 |
| A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale DR-1031, Seasonale®, Portia® - Breakthrough Bleeding | Phase 2 | Completed | Duramed Research | 567 | 2006-10-01 | 2013-07-26 |
| A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001 DR-5001, Placebo - Respiratory Tract Diseases | Phase 3 | Completed | Duramed Research | 4040 | 2006-09-01 | 2017-04-10 |
| Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive DR-1021 - Contraception | Phase 3 | Completed | Duramed Research | 1347 | 2006-08-01 | 2013-08-21 |
| A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy DR-2041a, DR-2041b, Placebo - Menopause | Phase 3 | Completed | Duramed Research | 622 | 2006-08-01 | 2015-04-20 |
| A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes Cenestin 0.3 mg Tablets, Placebo - Hot Flashes | Phase 3 | Completed | Duramed Research | 400 | 2005-12-01 | 2012-07-03 |
| A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea DR-2021a, DR-2021b, DR-2021c - Amenorrhea | Phase 2 | Completed | Duramed Research | 180 | 2005-09-01 | 2014-07-30 |
| Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density Seasonale (levonorgestrel and ethinyl estradiol) - Osteopenia | Phase 3 | Withdrawn | Duramed Research | 2005-07-01 | 2013-08-12 | |
| Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive DR-1011 - Contraception | Phase 3 | Completed | Duramed Research | 2235 | 2005-06-01 | 2016-11-16 |
| A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients Cyproterone acetate 5, Placebo, Cyproterone acetate 15 - Prostate Cancer | Phase 2 | Completed | Duramed Research | 315 | 2005-06-01 | 2016-07-22 |
| Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement DR-2011, Progesterone 8% Vaginal Gel - Infertility | Phase 2 | Completed | Duramed Research | 20 | 2005-06-01 | 2014-05-12 |
| Evaluation of DR-2001 for the Management of Endometriosis-Related Pelvic Pain DR-2001a, DR-2001b, Placebo - Endometriosis | Phase 2 | Completed | Duramed Research | 90 | 2005-06-01 | 2014-05-09 |
| A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)], Seasonique (LNG/EE and EE), Portia (LNG/EE) - Healthy | Phase 3 | Completed | Duramed Research | 36 | 2005-06-01 | 2014-05-09 |
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Urinary Bladder, Overactive (3) · Amenorrhea (2) · Dysmenorrhea (2) · Hot Flashes (2) · Infertility (2) · Adenoviridae Infections (1) · Bone Diseases, Metabolic (1) · Dyspareunia (1) · Endometriosis (1) · Metrorrhagia (1) · Migraine Disorders (1) · Pelvic Pain (1) · Prostatic Neoplasms (1) · Respiratory Tract Diseases (1) · Urinary Incontinence (1)
Seasonique (6) · Ethinyl Estradiol-Norgestrel Combination (5) · Levonorgestrel (3) · Seasonale (3) · Progesterone (2) · estrogens, conjugated synthetic A (2) · estrogens, conjugated synthetic B (2) · Crinone (1) · Ethinyl Estradiol (1) · Vaginal Creams, Foams, and Jellies (1)
United States (23) · Canada (3)
Jen Henrick (1)
PMID 18053998, PMID 19252451, PMID 20004272, PMID 22183214, PMID 23465817, PMID 30396554, PMID 37160401