Infertility Clinical Trial
Official title:
Randomized, Controlled, Open-label, Parallel, Clinical Trial to Assess Pharmacokinetics and Endometrial Effect of an Injectable Formulation of Progesterone Microspheres in Doses of 50 mg, 100 mg, 200 mg and 300 mg, in Postmenopausal Women.
Verified date | October 2011 |
Source | Productos Científicos S. A. de C. V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ministry of Health |
Study type | Interventional |
Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the
minimum effective dose of progesterone microspheres suspension, which administered by weekly
intramuscular injection, will be able to induce transformation from a proliferative
endometrium to a secretory endometrium.
Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial.
Sites: 1 Subjects: 48 postmenopausal women.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Asociación Mexicana para la Investigación Clínica, A. C. (AMIC) | Pachuca | Hidalgo |
Lead Sponsor | Collaborator |
---|---|
Productos Científicos S. A. de C. V. |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endometrial dating through histopathologic criteria. | Endometrial dating according Noyes criteria as a measure of efficacy. At the moment of the biopsy, study subjects would have received 25 days of estradiol valerate pretreatment and 10 days of progesterone (investigational product); thus simulating the 25th day of a menstrual cycle. Efficacy will be measured as number of biopsies that have histological date according to cronological date. | 10 days | No |
Secondary | Pharmacokinetics | Progesterone plasmatic concentrations and pharmacokinetic parameters. | 0 -60 days. | No |
Secondary | Adverse events | Number of Participants with Adverse Events as a Measure of Safety and Tolerability Pain Scores on a Visual Analog Scale | 0 - 65 days | Yes |
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