Postmenopausal EndometriumPhase 1/2NCT01057511
Compare the Difference of P4 Concentration in Serum and Endometrium After Vaginal and IM P Administration
A Phase 1/2 study testing Crinone 8% and Progesterone in people with Postmenopausal Endometrium, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Crinone is a micronized progesterone gel which is administrated via vaginal route and targeted drug delivery to uterine (first uterine pass effect) with lower serum concentration. Read more about this study
- Who is it for?
- Ages Up to 55 years, women only
- Conditions the study is for
- Postmenopausal Endometrium
- What is being tested?
- Crinone 8% and Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Feb 2012
- Phase
- Phase 1/2
- 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 Up to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Perimenopausal women aged <55 years old with amenorrhea>=2 months or reproductive aged women with amenorrhea >= 6months due to premature ovarian failure or other reasons.;
- Serum progesterone level < 1ng/mL
- Endometrial thickness ≥5mm
- No contraindication of progesterone administration;
- Informed consent is signed.
Who cannot join
- The other kind of progestin was applied 1 month before recruitment;
- Any serious diseases that does not allow to receive the progestin treatment;
- Under any vaginal treatment;
- Any vaginal infectious disease;
- Any other hormone treatment contraindications;
- drug abuse or untreated STD;
- Prior hypersensitivity to Crinone or one of their excipients.
- Pregnant women who indicate hCG positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Differences of Progesterone Concentration in Serum and Endometrium After Administration With Vaginal and Intramuscular Progesterone
Crinone is a micronized progesterone gel which is administrated via vaginal route and targeted drug delivery to uterine (first uterine pass effect) with lower serum concentration. This study is to investigate the difference of progesterone concentration in serum and endometrium after administration with crinone and intramuscular progesterone.
The study will be conducted as a single centre, randomized, active controlled study. Recruitment duration will be 6-8 months long. Day 1 of Crinone administration will be the baseline. On Day 7 of Crinone administration endometrial tissue will be taken for P4 test. Last visit will be at 3-5 days after withdraw bleeding.
- Conditions
- Postmenopausal Endometrium
- Being tested
- Crinone 8%, Progesterone
- Keywords
- Crinone, progesterone, endometrial progesterone concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crinone 8%Drug
Also called progesterone vaginal gel
Crinone 8%, 90mg / p.v. / Qd, 7 days totally.
ProgesteroneDrug
Also called IMP
Progesterone 20mg/ i.m./ Qd, 7 days totally.
| Study group | Role | What they receive |
|---|---|---|
| progesterone | Active comparator | Each subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally Receives: Drug: Progesterone |
| Crinone 8% | Experimental | Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally. Receives: Drug: Crinone 8% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: progesterone level in endometrium and in serum
The women who singed informed consent were randomized into two groups, respectively received Crinone 90mg via vaginal route or progesterone 20mg via IM route, once per day, for seven days. After 7 days therapy, endometrium biopsy was taken via vaginal route for tissue P concentration test by radioimmunoassay method. Blood sample were drawn for serum progesterone level.
Measured: after 7 days of progesterone therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionAug 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal EndometriumStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono International SA
- Responsible party
- Sponsor
- Investigators
- AIJUN SUN, PhD, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057511
- Sponsor's protocol ID
- EMR200113-600
- Status last verified
- Apr 2012
- First submitted
- 26 Jan 2010
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Differences of Progesterone Concentration in Serum and Endometrium After Administration With Vaginal and Intramuscular Progesterone
- ClinicalTrials.gov ID
- NCT01057511
- Acronym / sponsor ID
- EMR200113-600
- Conditions
- Postmenopausal Endometrium
- Keywords
- Crinone, progesterone, endometrial progesterone concentration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Merck Serono International SA
- Study start
- Dec 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Jan 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.
Crinone is a micronized progesterone gel which is administrated via vaginal route and targeted drug delivery to uterine (first uterine pass effect) with lower serum concentration. This study is to investigate the difference of progesterone concentration in serum and endometrium after administration with crinone and intramuscular progesterone.
The study will be conducted as a single centre, randomized, active controlled study. Recruitment duration will be 6-8 months long. Day 1 of Crinone administration will be the baseline. On Day 7 of Crinone administration endometrial tissue will be taken for P4 test. Last visit will be at 3-5 days after withdraw bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progesterone | Active comparator | Drug: ProgesteroneEach subject in this group will be give progesterone oil 20mg via intramuscular route once a day for 7 days totally |
| Crinone 8% | Experimental | Drug: Crinone 8%Each subjects in this group will be given Crinone 8% 90mg via vaginal route once a day for 7 days totally. |
Who may qualify
- Ages
- Up to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Perimenopausal women aged <55 years old with amenorrhea>=2 months or reproductive aged women with amenorrhea >= 6months due to premature ovarian failure or other reasons.;
- Serum progesterone level < 1ng/mL
- Endometrial thickness ≥5mm
- No contraindication of progesterone administration;
- Informed consent is signed.
Key exclusion criteria (8 listed)
- The other kind of progestin was applied 1 month before recruitment;
- Any serious diseases that does not allow to receive the progestin treatment;
- Under any vaginal treatment;
- Any vaginal infectious disease;
- Any other hormone treatment contraindications;
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 |
|---|---|---|
| Crinone 8%Also: progesterone vaginal gelCrinone 8%, 90mg / p.v. / Qd, 7 days totally. | Drug | Crinone 8% |
| ProgesteroneAlso: IMPProgesterone 20mg/ i.m./ Qd, 7 days totally. | Drug | progesterone |
Primary outcome
Primary endpoint: progesterone level in endometrium and in serum
Time frame: after 7 days of progesterone therapy
The women who singed informed consent were randomized into two groups, respectively received Crinone 90mg via vaginal route or progesterone 20mg via IM route, once per day, for seven days. After 7 days therapy, endometrium biopsy was taken via vaginal route for tissue P concentration test by radioimmunoassay method. Blood sample were drawn for serum progesterone level.
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 3 Apr 2012.
Related trials for Postmenopausal Endometrium
Not yet recruitingPhase 4
Low Dose Aspirin to Lower Inflammation and Prevent Endometrial Cancer in Postmenopausal Women With Non-atrophic Endometrial Changes and Pain
Endometrial Carcinoma
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Hysteroscopic Findings With Histopathologic Report of Endometrium in Patients With Postmenopausal Bleeding
Postmenopausal Bleeding
Not yet recruitingObservational study
Asymptomatic Women With Thick Endometrium: Hysteroscopic and Histopathological Report
Endometrial, Asymptomatic Post-menopause
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.
AIJUN SUN, PhD, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Crinone 8% and Progesterone in people with Postmenopausal Endometrium, run by Peking Union Medical College Hospital at 1 site in China.
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 5 inclusion and 8 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 3 Apr 2012. 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 China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Primary endpoint: progesterone level in endometrium and in serum (time frame: after 7 days of progesterone therapy). 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 3 Apr 2012.