Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women
Stopped early · Phase 3
Conditions studied: Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
In brief
To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena®
Key facts
- Study ID
- NCT02937766
- Run by
- AMAG Pharmaceuticals, Inc.
- People needed
- 60
- Starts
- 2016-10-07
- Expected to finish
- 2017-03-27
- Last updated by the study team
- 2022-04-21
Who can join
Age: 50 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit.
- Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL.
- Naturally or surgically postmenopausal with or without an intact uterus.
You may not qualify if…
- Have history of or positive test results for HIV or hepatitis B or C.
- A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition.
- Receiving or have received chronic opioid therapy within 12 months.
- Unwilling to stop taking/using:
- pain medication.
- topical analgesic or anti-inflammatory treatment. Topical analgesics must be washed out by at least 72 hours in the areas to be treated before randomization.
- History of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months.
- Currently taking any estrogen/progesterone hormone replacement therapy (HRT).
- History of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or any of the constituents of the study medications or history of any drug hypersensitivity or intolerance.
- Poorly controlled diabetes (Hgb A1C >8).
- Current or history of thrombosis or thromboembolic disorders.
- Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years.
- Any current or recent (within previous 12 months) vaginal bleeding.
- Uncontrolled hypertension.
- A chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain.
Where it is running
- Lotus Clinical Research, LLC — Pasadena, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.