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

Last updated: March 31, 2022
Sponsor: AMAG Pharmaceuticals, Inc.
Overall Status: Terminated

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02937766
AMAG-HPC-HPM-301
  • Ages 50-75
  • Female
  • Accepts Healthy Volunteers

Study Summary

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®

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit.
  2. Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL.
  3. Naturally or surgically postmenopausal with or without an intact uterus.

Exclusion

Exclusion Criteria:

  1. Have history of or positive test results for HIV or hepatitis B or C.
  2. A significant history or current evidence of chronic infectious disease, organdysfunction especially cardiovascular, renal, or hepatic disorders or other medicalcondition.
  3. Receiving or have received chronic opioid therapy within 12 months.
  4. Unwilling to stop taking/using:
  • pain medication.
  • topical analgesic or anti-inflammatory treatment. Topical analgesics must bewashed out by at least 72 hours in the areas to be treated before randomization.
  1. History of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months.
  2. Currently taking any estrogen/progesterone hormone replacement therapy (HRT).
  3. History of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or anyof the constituents of the study medications or history of any drug hypersensitivityor intolerance.
  4. Poorly controlled diabetes (Hgb A1C >8).
  5. Current or history of thrombosis or thromboembolic disorders.
  6. Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or historyof these conditions within the last 5 years.
  7. Any current or recent (within previous 12 months) vaginal bleeding.
  8. Uncontrolled hypertension.
  9. A chronic pain condition (i.e. chronic back pain) that may confound the assessments ofinjection pain.

Study Design

Total Participants: 60
Study Start date:
October 07, 2016
Estimated Completion Date:
March 27, 2017

Connect with a study center

  • Lotus Clinical Research, LLC

    Pasadena, California 91105
    United States

    Site Not Available

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