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Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

NCT ID: NCT01176175

Last Updated: 2011-10-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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 transformation from a proliferative endometrium to a secretory endometrium.

Secondary objectives:

* To determine and compare the steady-state pharmacokinetic profile of investigational products.
* To evaluate safety profile of investigational products in the study subjects.
* To evaluate local tolerability of investigational products in the study subjects.

Study design:Randomized, controlled, open-label, parallel, dose-response clinical trial.

Investigational products:

* Progesterone microspheres intramuscular injectable suspension 50 mg
* Progesterone microspheres intramuscular injectable suspension 100 mg
* Progesterone microspheres intramuscular injectable suspension 200 mg
* Progesterone microspheres intramuscular injectable suspension 300 mg Study subjects: 48 healthy postmenopausal women, 45 - 60 years. Brief description: After written informed consent, 48 eligible women will receive pretreatment with oral estradiol valerate, then, 14 days later, those with adequate endometrial thickness evaluated through ultrasound will be randomized to study treatments (one IM injection each 7 days, for a total of 7 doses). 10 days after the first progesterone dose, an endometrial biopsy will be obtained. Blood samples will be obtained for pharmacokinetic study.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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50 mg

Progesterone microspheres injectable suspension 50 mg

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

Progesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses.

100 mg

Progesterone microspheres injectable suspension 100 mg

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

Progesterone microspheres injectable suspension 100 mg, intramuscular weekly injection for a total of 7 doses.

200 mg

Progesterone microspheres injectable suspension 200 mg

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

Progesterone microspheres injectable suspension 200 mg, intramuscular weekly injection for a total of 7 doses.

300 mg

Progesterone microspheres injectable suspension 300 mg

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

Progesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses.

Interventions

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Progesterone

Progesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses.

Intervention Type DRUG

Progesterone

Progesterone microspheres injectable suspension 100 mg, intramuscular weekly injection for a total of 7 doses.

Intervention Type DRUG

Progesterone

Progesterone microspheres injectable suspension 200 mg, intramuscular weekly injection for a total of 7 doses.

Intervention Type DRUG

Progesterone

Progesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Productos Científicos S. A. de C. V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Roberto Bernardo Escudero

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto Bernardo, MD 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

Site Status

Countries

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Mexico

Other Identifiers

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0908/I/PRO

Identifier Type: -

Identifier Source: org_study_id