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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
Sites: 1
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estradiol 0.5 mg/Progesterone 15 mg microspheres | Experimental | Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension |
|
| Estradiol 1 mg/Progesterone 20 mg microspheres | Experimental | Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol + Progesterone | Drug | Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Estrogen and progesterone plasma concentrations and pharmacokinetic parameters. | 0 - 60 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number of Participants with Adverse Events as a Measure of Safety and Tolerability. Adverse events will be evaluated through periodic clinical evaluations and laboratory tests (comparison between enrollment and discharge). | 0 - 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Bernardo, MSc | Asociación Mexicana para la Investigación Clínica, A. C. (AMIC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Mexicana para la Investigación Clínica, A. C. (AMIC) | Pachuca | Hidalgo | 42090 | Mexico |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Estradiol + Progesterone | Drug | Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses. |
|
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |