MenopausePhase 1NCT01293747
Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension
A Phase 1 study testing Estradiol + Progesterone in people with Menopause, run by Productos Científicos S. A. de C. V. at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Estradiol + Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2011to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
Pachuca, Hidalgo, 42090
About this study
Official title: Multiple-dose Pharmacokinetic Study of Two Aqueous Suspensions of Estradiol and Progesterone Microspheres (1 mg/20 mg & 0.5 mg/15 mg) for Intramuscular Administration, in Postmenopausal Volunteers.
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
Read the detailed description
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:
- 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
- Menopause
- Being tested
- Estradiol + Progesterone
- Keywords
- Estrogen, Progesterone, Microspheres, Menopause, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol + ProgesteroneDrug
Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
Estradiol + ProgesteroneDrug
Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| Estradiol 0.5 mg/Progesterone 15 mg microspheres | Experimental | Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension Receives: Drug: Estradiol + Progesterone |
| Estradiol 1 mg/Progesterone 20 mg microspheres | Experimental | Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension Receives: Drug: Estradiol + Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Estrogen and progesterone plasma concentrations and pharmacokinetic parameters.
Measured: 0 - 60 Days
Secondary outcomes (1)
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).
Measured: 0 - 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Productos Científicos S. A. de C. V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Roberto Bernardo Escudero, Productos Científicos S. A. de C. V.
- Investigators
- Roberto Bernardo, MSc, Principal investigator, Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293747
- Sponsor's protocol ID
- 0903/I/PRO
- Status last verified
- Oct 2011
- First submitted
- 10 Feb 2011
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose Pharmacokinetic Study of Two Aqueous Suspensions of Estradiol and Progesterone Microspheres (1 mg/20 mg & 0.5 mg/15 mg) for Intramuscular Administration, in Postmenopausal Volunteers.
- ClinicalTrials.gov ID
- NCT01293747
- Acronym / sponsor ID
- 0903/I/PRO
- Conditions
- Menopause
- Keywords
- Estrogen, Progesterone, Microspheres, Menopause, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Productos Científicos S. A. de C. V.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol 0.5 mg/Progesterone 15 mg microspheres | Experimental | Drug: Estradiol + ProgesteroneEstradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension |
| Estradiol 1 mg/Progesterone 20 mg microspheres | Experimental | Drug: Estradiol + ProgesteroneEstradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- 45 to 65 years old
- Able to read and write
- Postmenopausal
- Body Mass Index equal or below 34.99 kg/m2
Key exclusion criteria (19 listed)
- Hypersensitivity to progesterone or related compounds
- Hypersensitivity to estrogens
- Hysterectomy
- History or present hormone-dependent tumor
- History or present uterine cervix dysplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol + ProgesteroneEstradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses. | Drug | Estradiol 1 mg/Progesterone 20 mg microspheres |
| Estradiol + ProgesteroneEstradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses. | Drug | Estradiol 0.5 mg/Progesterone 15 mg microspheres |
Primary outcome
Pharmacokinetics
Time frame: 0 - 60 Days
Estrogen and progesterone plasma concentrations and pharmacokinetic parameters.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 0 - 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Bernardo, MSc principal investigator
Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Estradiol + Progesterone in people with Menopause, run by Productos Científicos S. A. de C. V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 0 - 60 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2011.