Last updated: March 31, 2022
Sponsor: AMAG Pharmaceuticals, Inc.
Overall Status: Completed
Phase
1
Condition
Colic
Stomach Discomfort
Lactose Intolerance
Treatment
N/AClinical Study ID
NCT03973047
AMAG-BMT-HSDD-102
Ages 18-55 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Willing and able to provide written informed consent prior to participating in thestudy.
- Female subjects ≥18 to 55 years of age (inclusive) and premenopausal as defined by themodified STRAW criteria (specifically, Stage -5 [menses variable to regular] throughStage 1 [≥2 skipped cycles and an interval of amenorrhea ≥60 days]).
- Able to communicate clearly with the Principle Investigator (PI) and staff; able toread English, complete questionnaires, and understand study procedures.
- Able to complete all screening period evaluations, stay in the clinic testing facilityfor minimum of 4 hours following dose of BMT.
- In good general health, free from clinically significant medical or psychiatricillness or disease (as determined by medical/surgical history, physical examination,weight, 12-lead ECG, and clinical laboratory tests).
Exclusion
Key Exclusion Criteria:
- Postmenopausal female, designated by having amenorrhea for ≥12 months.
- Has current or recent (within 6 months) history of gastrointestinal disease, or anysurgical or medical condition such as Crohn's disease or liver disease, that couldpotentially alter the absorption, metabolism, or excretion of the study drug.
- Has any clinically significant medical condition, physical exam finding, or ECGabnormality, or clinically significant abnormal value for hematology, serology,clinical chemistry, or urinalysis at Screening, or at admission to the study center,as assessed by the PI.
- Has any of the following:
- History or current diagnosis of uncontrolled hypertension defined as: Two (2)sequential assessments (at least 5 minutes apart and no more than 15 minutes apart) atlevels >140 mmHg SBP or 90 mmHg DBP and/or treatment for hypertension that has beenchanged at least once in the 4 weeks before Screening.
- Renal dysfunction (creatinine clearance < 80 mL/min using Cockcroft Gaultcalculation).
- History or presence of malignancy within the past 5 years, with the exception ofadequately treated localized skin cancer (basal cell or squamous cell carcinoma),which is allowed.
Study Design
Total Participants: 228
Study Start date:
June 17, 2019
Estimated Completion Date:
July 20, 2019
Study Description
Connect with a study center
ICON Early Phase Serrvices, LLC
San Antonio, Texas 78209
United StatesSite Not Available

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