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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR HYDROXYPROGESTERONE CAPROATE

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Clinical Trials for Hydroxyprogesterone Caproate

Trial ID Title Status Sponsor Phase Summary
NCT00099164 Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS) Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a treatment that substantially reduces the rate of preterm birth in women at high risk for preterm delivery (i.e. progesterone therapy). Preterm birth was reduced by 35% among progesterone-treated women with a singleton pregnancy when compared with women receiving placebo. The current trial compares weekly treatment by injection of progesterone with placebo in women pregnant with twins or triplets.
NCT00099164 Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS) Completed The George Washington University Biostatistics Center Phase 3 Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a treatment that substantially reduces the rate of preterm birth in women at high risk for preterm delivery (i.e. progesterone therapy). Preterm birth was reduced by 35% among progesterone-treated women with a singleton pregnancy when compared with women receiving placebo. The current trial compares weekly treatment by injection of progesterone with placebo in women pregnant with twins or triplets.
NCT00120640 Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate Withdrawn Yale University N/A The goal of our research will be to determine the effectiveness of 17 alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with progesterone is emerging as the standard of care for prevention of preterm delivery in asymptomatic patients at high risk for preterm birth due to a prior preterm delivery. Our goal is to evaluate whether or not progesterone is also effective in reducing preterm birth in symptomatic patients.
NCT00135902 Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is: "Among women at high risk for preterm birth receiving weekly injections of 17P, the addition of Omega-3 nutritional supplement will further reduce the rate of preterm birth."
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Hydroxyprogesterone Caproate

Condition Name

Condition Name for Hydroxyprogesterone Caproate
Intervention Trials
Preterm Birth 7
Premature Birth 4
Pregnancy 4
Preterm Delivery 3
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Condition MeSH

Condition MeSH for Hydroxyprogesterone Caproate
Intervention Trials
Premature Birth 16
Obstetric Labor, Premature 3
Rupture 2
Pregnancy Complications 1
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Clinical Trial Locations for Hydroxyprogesterone Caproate

Trials by Country

Trials by Country for Hydroxyprogesterone Caproate
Location Trials
United States 115
Hungary 6
Czech Republic 4
Canada 4
Russian Federation 2
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Trials by US State

Trials by US State for Hydroxyprogesterone Caproate
Location Trials
Texas 8
Pennsylvania 8
California 7
North Carolina 6
Michigan 6
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Clinical Trial Progress for Hydroxyprogesterone Caproate

Clinical Trial Phase

Clinical Trial Phase for Hydroxyprogesterone Caproate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 9
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Hydroxyprogesterone Caproate
Clinical Trial Phase Trials
Completed 10
Recruiting 8
Terminated 2
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Clinical Trial Sponsors for Hydroxyprogesterone Caproate

Sponsor Name

Sponsor Name for Hydroxyprogesterone Caproate
Sponsor Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 6
AMAG Pharmaceuticals, Inc. 4
Lumara Health, Inc. 3
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Sponsor Type

Sponsor Type for Hydroxyprogesterone Caproate
Sponsor Trials
Other 21
Industry 9
NIH 7
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