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Generated: March 26, 2019

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CLINICAL TRIALS PROFILE FOR MAKENA

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Clinical Trials for Makena

Trial ID Title Status Sponsor Phase Summary
NCT01004029 Confirmatory Study of 17P Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery Recruiting AMAG Pharmaceuticals, Inc. Phase 3 As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.
NCT01004029 Confirmatory Study of 17P Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery Recruiting ResearchPoint Global Phase 3 As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.
NCT01004029 Confirmatory Study of 17P Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery Recruiting Lumara Health, Inc. Phase 3 As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.
NCT01119963 Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) Completed Obstetrix Medical Group Phase 2/Phase 3 The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1. increase the probability of continuing the pregnancy until a favorable gestational age. 2. increase the interval between randomization and delivery. 3. decrease neonatal morbidity.
NCT01899846 Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood Completed Lumara Health, Inc. Phase 1 This study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in blood throughout pregnancy There will be 3 cohorts of subjects Cohort 1 (6 subjects) will have daily blood draws in the morning at approximately the same time each day for one week following their first dose of Makena and will have blood drawn immediately prior to 2 successive Makena doses during Epoch 1 (24 - 28 weeks) and Epoch 2 (32 - 36 weeks) Cohort 2 (8 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of Makena. Subjects will have daily blood draws for one week following a dose of Makena given in Epoch 1 (24 - 28 weeks) and blood drawn immediately prior to 2 successive doses during Epoch 2 (32 - 36 weeks) Cohort 3 (16 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of Makena. Subjects will have blood drawn immediately prior to 2 successive doses in Epoch 1 (24 - 28 weeks) and daily blood draws for one week following a dose of Makena given during Epoch 2 (32 - 36 weeks) A maximum of 10 subjects will be monitored on selected days following a completed course of Makena therapy to determine the terminal elimination phase.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Makena

Condition Name

Condition Name for Makena
Intervention Trials
Preterm Delivery 1
Preterm Birth 1
Premature Birth 1
Pregnancy 1
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Condition MeSH

Condition MeSH for Makena
Intervention Trials
Premature Birth 3
Rupture 1
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Clinical Trial Locations for Makena

Trials by Country

Trials by Country for Makena
Location Trials
United States 48
Canada 3
Czech Republic 3
Italy 2
Hungary 2
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Trials by US State

Trials by US State for Makena
Location Trials
California 4
Florida 3
Texas 2
Massachusetts 2
Missouri 2
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Clinical Trial Progress for Makena

Clinical Trial Phase

Clinical Trial Phase for Makena
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Makena
Clinical Trial Phase Trials
Recruiting 4
Completed 2
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Clinical Trial Sponsors for Makena

Sponsor Name

Sponsor Name for Makena
Sponsor Trials
AMAG Pharmaceuticals, Inc. 3
Lumara Health, Inc. 2
ResearchPoint Global 1
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Sponsor Type

Sponsor Type for Makena
Sponsor Trials
Industry 6
Other 4
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