InfertilityPhase 1NCT01176175
Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study
A Phase 1 study testing Progesterone in people with Infertility, run by Productos Científicos S. A. de C. V. at 1 site in Mexico.
Trial 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 injection, will be able to induce transformation from a proliferative endometrium to a secretory endometrium. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2010to Feb 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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 20Show 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
- 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
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: 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.
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.
Read the 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 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
- Infertility
- Being tested
- Progesterone
- Keywords
- Progesterone, Microspheres, postmenopausal, Luteal phase support
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Progesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses.
ProgesteroneDrug
Progesterone microspheres injectable suspension 100 mg, intramuscular weekly injection for a total of 7 doses.
ProgesteroneDrug
Progesterone microspheres injectable suspension 200 mg, intramuscular weekly injection for a total of 7 doses.
ProgesteroneDrug
Progesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses.
| Study group | Role | What they receive |
|---|---|---|
| 50 mg | Experimental | Progesterone microspheres injectable suspension 50 mg Receives: Drug: Progesterone |
| 100 mg | Experimental | Progesterone microspheres injectable suspension 100 mg Receives: Drug: Progesterone |
| 200 mg | Experimental | Progesterone microspheres injectable suspension 200 mg Receives: Drug: Progesterone |
| 300 mg | Experimental | Progesterone microspheres injectable suspension 300 mg Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (2)
Pharmacokinetics
Progesterone plasmatic concentrations and pharmacokinetic parameters.
Measured: 0 -60 days.
Adverse events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability Pain Scores on a Visual Analog Scale
Measured: 0 - 65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 48 participants (actual)
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, MD MSc, Principal investigator, Asociación Mexicana para la Investigación Clínica, A. C. (AMIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176175
- Sponsor's protocol ID
- 0908/I/PRO
- Status last verified
- Oct 2011
- First submitted
- 4 Aug 2010
- 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
- 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.
- ClinicalTrials.gov ID
- NCT01176175
- Acronym / sponsor ID
- 0908/I/PRO
- Conditions
- Infertility
- Keywords
- Progesterone, Microspheres, postmenopausal, Luteal phase support
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Productos Científicos S. A. de C. V.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Aug 2010 (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 - 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50 mg | Experimental | Drug: ProgesteroneProgesterone microspheres injectable suspension 50 mg |
| 100 mg | Experimental | Drug: ProgesteroneProgesterone microspheres injectable suspension 100 mg |
| 200 mg | Experimental | Drug: ProgesteroneProgesterone microspheres injectable suspension 200 mg |
| 300 mg | Experimental | Drug: ProgesteroneProgesterone microspheres injectable suspension 300 mg |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female
- 45 to 60 years old
- Able to read and write
- Postmenopausal
- Body Mass Index equal or below 34.99 kg/m2
Key exclusion criteria (20 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 |
|---|---|---|
| ProgesteroneProgesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses. | Drug | 50 mg |
| ProgesteroneProgesterone microspheres injectable suspension 100 mg, intramuscular weekly injection for a total of 7 doses. | Drug | 100 mg |
| ProgesteroneProgesterone microspheres injectable suspension 200 mg, intramuscular weekly injection for a total of 7 doses. | Drug | 200 mg |
| ProgesteroneProgesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses. | Drug | 300 mg |
Primary outcome
Endometrial dating through histopathologic criteria.
Time frame: 10 days
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.
2 secondary outcomes
Pharmacokinetics
Time frame: 0 -60 days.
Adverse events
Time frame: 0 - 65 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.
Related trials for Infertility
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
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, MD 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 Progesterone in people with Infertility, 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 20 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?
Endometrial dating through histopathologic criteria. (time frame: 10 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.