Last updated: March 31, 2022
Sponsor: AMAG Pharmaceuticals, Inc.
Overall Status: Terminated
Phase
3
Condition
N/ATreatment
N/AClinical Study ID
NCT02937766
AMAG-HPC-HPM-301
Ages 50-75 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
Exclusion
Exclusion Criteria:
- Have history of or positive test results for HIV or hepatitis B or C.
- A significant history or current evidence of chronic infectious disease, organdysfunction especially cardiovascular, renal, or hepatic disorders or other medicalcondition.
- 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 bewashed 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, 3oz. 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 anyof the constituents of the study medications or history of any drug hypersensitivityor 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 historyof 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 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 StatesSite Not Available
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