Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension
Multiple-dose Pharmacokinetic Study of Two Aqueous Suspensions of Estradiol and Progesterone Microspheres (1 mg/20 mg & 0.5 mg/15 mg) for Intramuscular Administration, in Postmenopausal Volunteers.
1 other identifier
interventional
30
1 country
1
Brief Summary
Phase I pharmacokinetic study Main objective: To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study Sites: 1 Subjects: 30 postmenopausal women
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 13, 2011
October 1, 2011
6 months
February 10, 2011
October 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics
Estrogen and progesterone plasma concentrations and pharmacokinetic parameters.
0 - 60 Days
Secondary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
0 - 60 days
Study Arms (2)
Estradiol 0.5 mg/Progesterone 15 mg microspheres
EXPERIMENTALEstradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension
Estradiol 1 mg/Progesterone 20 mg microspheres
EXPERIMENTALEstradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension
Interventions
Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Eligibility Criteria
You may qualify if:
- Female
- to 65 years old
- Able to read and write
- Postmenopausal
- Body Mass Index equal or below 34.99 kg/m2
- Healthy
- Normal uterus
- Time availability
You may not qualify if:
- Hypersensitivity to progesterone or related compounds
- Hypersensitivity to estrogens
- Hysterectomy
- History or present hormone-dependent tumor
- History or present uterine cervix dysplasia
- Abnormal and clinically-significant laboratory test results
- Family history of breast cancer
- History of thromboembolic disease
- Non-controlled hypertension
- History of stroke
- History of cardiac valve surgery
- Renal failure
- Hepatic failure
- Non-controlled diabetes
- History of serious neurologic disease
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
Pachuca, Hidalgo, 42090, Mexico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto Bernardo, MSc
Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
February 1, 2011
Primary Completion
August 1, 2011
Study Completion
October 1, 2011
Last Updated
October 13, 2011
Record last verified: 2011-10