Status:
COMPLETED
Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study
Lead Sponsor:
Productos Científicos S. A. de C. V.
Conditions:
Infertility
Eligibility:
FEMALE
45-60 years
Phase:
PHASE1
Brief Summary
Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the minimum effective dose of progesterone microspheres suspension, which administered by weekly intramuscular in...
Detailed Description
Sites: 1 Phase: 1 Main objective:To establish the minimum effective dose of progesterone microspheres suspension, which administered by weekly intramuscular injection, will be able to induce transform...
Eligibility Criteria
Inclusion
- Female
- 45 to 60 years old
- Able to read and write
- Postmenopausal
- Body Mass Index equal or below 34.99 kg/m2
- Healthy
- Normal uterus
- Time availability
Exclusion
- 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
- Severe gastrointestinal disease
- History of serious neurologic disease
- Reduced mobility
- Anemia
- Previous or concomitant hormonal therapy
- Previous or concomitant therapy with inhibitors or inductors of cytochrome
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01176175
Start Date
August 1 2010
End Date
February 1 2011
Last Update
October 13 2011
Active Locations (1)
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1
Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
Pachuca, Hidalgo, Mexico, 42090