Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension
NCT ID: NCT01293747
Last Updated: 2011-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2011-02-28
2011-10-31
Brief Summary
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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
Detailed Description
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Phase: 1
Main objective:
To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration.
Secondary objectives:
To determine bioavailability of each of the formulations studied, after multiple-dose-administration. Describe tolerability of each of the formulations studied, after multiple-dose administration.
Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study
Investigational Products:
* Estradiol and progesterone microspheres aqueous suspension (1 mg/20 mg)
* Estradiol and progesterone microspheres aqueous suspension (0.5 mg/15 mg)
Study subjects: 30 postmenopausal women 45 - 65 years old
Brief description: After written informed consent, 30 eligible women will be randomized to study treatments (one IM injection each 28 days, for a total of 4 doses). Blood samples will be obtained for pharmacokinetic study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Estradiol 0.5 mg/Progesterone 15 mg microspheres
Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension
Estradiol + Progesterone
Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Estradiol 1 mg/Progesterone 20 mg microspheres
Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension
Estradiol + Progesterone
Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Interventions
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Estradiol + Progesterone
Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Estradiol + Progesterone
Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Eligibility Criteria
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Inclusion Criteria
* 45 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
Exclusion Criteria
* 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
* Reduced mobility
* Anemia
* Previous or concomitant hormone therapy
* Previous or concomitant therapy with inhibitors or inductors of cytochrome
45 Years
65 Years
FEMALE
Yes
Sponsors
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Productos Científicos S. A. de C. V.
INDUSTRY
Responsible Party
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Roberto Bernardo Escudero
Principal Investigator
Principal Investigators
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Roberto Bernardo, MSc
Role: PRINCIPAL_INVESTIGATOR
Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
Locations
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Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
Pachuca, Hidalgo, Mexico
Countries
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Other Identifiers
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0903/I/PRO
Identifier Type: -
Identifier Source: org_study_id