HealthyPhase 1NCT00830414
Medroxyprogesterone Acetate Injection 150 mg/1 mL in Postmenopausal Women
A Phase 1 study testing medroxyprogesterone acetate in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Germany.
Trial summary
This study compared the rates and extents of medroxyprogesterone absorption from two medroxyprogesterone acetate injection formulations following single 150 mg intramuscular (IM) injections to healthy postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- medroxyprogesterone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2002to Sep 2002
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Screening Demographics: All volunteers selected for this study will be healthy postmenopausal women 45 years of age or older at the time of dosing. The weight range will not exceed ±20% for height and body frame as per Desirable Weights for Women - 1983 Metropolitan Height and Weight Table.
- Screening Procedures: Each volunteer will complete the screening process within 28 days prior to period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and pulse, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
- Screening will include a Gynecological examination (PAP smear, breast) which does not show clinically relevant findings, e.g. a cytological smear classified according to Papanicolau (PAP) higher than grade II.
- The screening clinical laboratory procedures will include:
- HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
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- CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase
- HIV antibody, hepatitis GB surface antigen, and anti hepatitis C virus screens
- URINALYSIS: by dipstick; full microscopic examination if dipstick positive
- URINE DRUG SCREEN: amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, and opiates
- Ethyl alcohol will be measured using breath test (alcomat)
- FSH (to verify postmenopausal status)
- 17β-Estradiol (to verify postmenopausal status)
- SERUM PREGNANCY SCREEN
- Is female and:
- o Is postmenopausal for at least 1 year and has a serum FSH level greater than or equal to 30 mIU/mL and a serum 17β-estradiol level less than 30 pg/mL.
Who cannot join
- Volunteers with a recent history of drug or alcohol addiction or abuse.
- Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, gynecologic or neurologic system(s) or psychiatric disease (as determined by the clinical investigators or co-investigators).
- Volunteers whose clinical laboratory test values show clinically relevant deviations from normal when confirmed on re-examination.
- Volunteers demonstrating a positive hepatitis B surface antigen screen, a positive anti HCV screen or a reactive HIV antibody screen.
- Volunteers demonstrating a positive drug abuse screen when screened for this study.
- Volunteers demonstrating a positive pregnancy screen.
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- Volunteers with a history of allergic response(s) to medroxyprogesterone acetate or related drugs.
- Volunteers with a history of clinically significant allergies including drug allergies.
- Volunteers with a history of undiagnosed vaginal bleeding.
- Volunteers with personal or immediate family (mother, sister, daughter) history of breast cancer.
- Volunteers with a history of thromboembolic disorder, thrombophlebitis, or history of anticoagulant use other than aspirin.
- Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators or co-investigators).
- Volunteers who currently use tobacco products.
- Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
- Volunteers who report donating greater than 450 mL of blood within 30 days prior to dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- Volunteers who report receiving any investigational drug within 30 days prior to dosing.
- Volunteers who report taking any systemic prescription medication in the 14 days prior to dosing (for hormone replacement therapy (HRT) 4 weeks prior to dosing).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal Study to Evaluate the Bioequivalence of 150 mg/1 mL Medroxyprogesterone Acetate Injection in Postmenopausal Women
This study compared the rates and extents of medroxyprogesterone absorption from two medroxyprogesterone acetate injection formulations following single 150 mg intramuscular (IM) injections to healthy postmenopausal women.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- medroxyprogesterone acetate
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medroxyprogesterone acetateDrug
IM Injection
medroxyprogesterone acetateDrug
Also called DEPO-PROVERA®
IM injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: medroxyprogesterone acetate |
| 2 | Active comparator | DEPO-PROVERA® Receives: Drug: medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startApr 2002
- Primary completionSep 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Horst Jurgen Heuer, M.D., Principal investigator, AAI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830414
- Sponsor's protocol ID
- LA486
- Status last verified
- Aug 2024
- First submitted
- 26 Jan 2009
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study to Evaluate the Bioequivalence of 150 mg/1 mL Medroxyprogesterone Acetate Injection in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00830414
- Acronym / sponsor ID
- LA486
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 27 Jan 2009 (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.
This study compared the rates and extents of medroxyprogesterone absorption from two medroxyprogesterone acetate injection formulations following single 150 mg intramuscular (IM) injections to healthy postmenopausal women.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: medroxyprogesterone acetate |
| 2 | Active comparator | Drug: medroxyprogesterone acetateDEPO-PROVERA® |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Screening Demographics: All volunteers selected for this study will be healthy postmenopausal women 45 years of age or older at the time of dosing. The weight range will not exceed ±20% for height and body frame as per Desirable Weights for Women - 1983 Metropolitan Height and Weight Table.
- Screening Procedures: Each volunteer will complete the screening process within 28 days prior to period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and pulse, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
- Screening will include a Gynecological examination (PAP smear, breast) which does not show clinically relevant findings, e.g. a cytological smear classified according to Papanicolau (PAP) higher than grade II.
- HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
Key exclusion criteria (18 listed)
- Volunteers with a recent history of drug or alcohol addiction or abuse.
- Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, gynecologic or neurologic system(s) or psychiatric disease (as determined by the clinical investigators or co-investigators).
- Volunteers whose clinical laboratory test values show clinically relevant deviations from normal when confirmed on re-examination.
- Volunteers demonstrating a positive hepatitis B surface antigen screen, a positive anti HCV screen or a reactive HIV antibody screen.
- Volunteers demonstrating a positive drug abuse screen when screened for this study.
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 |
|---|---|---|
| medroxyprogesterone acetateIM Injection | Drug | 1 |
| medroxyprogesterone acetateAlso: DEPO-PROVERA®IM injection | Drug | 2 |
Primary outcome
Bioequivalence based on Cmax and AUC
Time frame: 120 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 19 Aug 2024.
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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.
Horst Jurgen Heuer, M.D. principal investigator
AAI
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 medroxyprogesterone acetate in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Germany.
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 16 inclusion and 18 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 19 Aug 2024. 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 Germany. 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?
Bioequivalence based on Cmax and AUC (time frame: 120 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 19 Aug 2024.