Putting our commitment into action

In collaboration with research physicians, Lumara Health is conducting several clinical studies that will add to the body of knowledge provided by the pivotal NICHD MFMU Network study of Hydroxyprogesterone Caproate (HPC)
(Meis NEJM 2003).

 

Ongoing clinical trials

  • Phase 3B safety and efficacy trial of Makena® (hydroxyprogesterone caproate injection) and companion studies:
    • This is the largest randomized controlled trial to date assessing the impact of progestogen therapy on reducing the risk of preterm birth.

      Lumara Health is currently enrolling patients for an international clinical trial of Makena to reduce the risk of recurrent preterm birth in its indicated population. The trial will be a sufficient size (more than 1,700 women) to detect outcome differences in neonatal morbidity and mortality and has already enrolled more than 700 patients (>50% in the U.S.).

    • The vast amount of data collected through the new trial will provide a robust platform for extensive secondary analysis. To assure maximum scientific value of this data, Lumara Health established a Publications Committee made up of leading researchers in the area of preterm birth. The Publications Committee is led by Sean C. Blackwell, MD, Chair, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Texas Health Science Center in Houston, Texas.
  • A companion follow-up study which will evaluate approximately 500 infants between the ages of 23 and 25 months who are born to the women enrolled in the Phase 3B trial.

Read more about the Phase 3B safety and efficacy trial of Makena and the recent patient enrollment milestone.

For more information on our clinical trials, visit .

 

  • "While the prior NICHD MFMU network trial demonstrated that this drug should be used for women with this obstetrical history, it is important that further research is done to understand the potential neonatal benefits. The vast amount of data collected through the new trial will also provide a robust platform for extensive secondary analyses."
    — Sean C. Blackwell, MD
    Chair, Department of Obstetrics, Gynecology and Reproductive Sciences
    at the University of Texas Health Science Center in Houston, Texas

 

Other Studies

Lumara Health is also conducting a clinical study to follow the pharmacokinetics of Makena (HPC) and its metabolites in plasma at various stages of pregnancy. This study completed enrollment of 30 patients in February 2014. Work is currently ongoing to identify the primary metabolites and validate analytical methods for their quantification. The results of this study, which is being conducted at seven research centers in the United States, will be published in 2014. For a list of participating centers .

 

External research

Lumara Health encourages independent investigator research on HPC. The company has an ongoing program to review clinical or nonclinical proposals and requests for support. If interested, please send a request for consideration to the Company via 

Ask a Healthcare Professional

 

Makena® is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

IMPORTANT SAFETY INFORMATION FOR MAKENA® (hydroxyprogesterone caproate injection)

Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to your current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.

Before you receive Makena, tell your healthcare provider if you have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in your urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).

Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes. Call your healthcare provider right away if you think you have symptoms of a blood clot (leg swelling, redness in your leg, a spot on your leg that is warm to touch, or leg pain that worsens when you bend your foot) or symptoms of an allergic reaction (hives, itching, or swelling of the face). The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

.