Cervical Intraepithelial NeoplasiaPhase 2NCT00247169
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II
A Phase 2 study testing progesterone in people with Cervical Intraepithelial Neoplasia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The investigators want to test whether treatment with a natural progesterone intravaginally increases the cure rate of cervical intraepithelial neoplasia grade I and II. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- progesterone
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2004to Apr 2010
- Phase
- Phase 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Histological evidence of CIN I and II
- Transformation zone and lesion margins fully visible
- Compliant subject
- Safe contraception
- Negative pregnancy test
Who cannot join
- Lesion related
- CIN III, (micro)-Invasive Cancer
- Endocervical lesion, upper margin of lesion not visible on colposcopy
- Non-compliance of patient
- PAP V
- Drug related
Show all 35Show fewer
- Age > 60
- Hypersensitivity to progesterone or any component of the formulation
- Thrombophlebitis
- Undiagnosed vaginal bleeding
- Carcinoma of the breast
- Cerebral apoplexy
- Severe liver dysfunction
- Pregnancy
- Depression
- Diabetes
- Epilepsy
- Migraine
- Renal dysfunction
- Asthma
- HIV infection
- Hepatitis B or C
- Concurrent use of anticoagulants
- Uncontrolled hypertension (> 160/90 mmHg)
- Breast cancer in personal history
- Concurrent hormonal therapy including OC
- Clinical laboratory related
- Hemoglobin < 11 g/dl
- Leukocytes < 4,0 x 109/L
- Platelet count < 100 x 109/L
- Serum bilirubin > 2 x above upper cut-off value
- Serum GOT > 2 x above upper cut-off value
- Serum GPT > 2 x above upper cut-off value
- Serum alkaline phosphatase > 2 x above upper cut-off value
- Serum creatinine > 2 x above cut-off value
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial
The investigators want to test whether treatment with a natural progesterone intravaginally increases the cure rate of cervical intraepithelial neoplasia grade I and II.
Read the detailed description
Background:
- The development of cervical intraepithelial neoplasia (CIN) was linked to a decreased local immune response as evidenced by a decrease of Langerhans' cell (LC) count in the cervical epithelium. Preliminary studies show that vaginally administered progesterone locally increases the number of LCs.
- There is no accepted treatment strategy of low grade CIN, i.e., CIN I and II, than await spontaneous regression.
Thus, vaginal progesterone is expected to increase the regression rate of cervical dysplasia grade I and II.
Outcome parameters:
Primary outcome parameters:
To evaluate whether or not a treatment with vaginal progesterone increases regression and remission rates of CIN I and II during a 6-month treatment period.
Secondary outcome parameters:
Change of immunohistochemically detected expression of LCs in CIN.
Methods:
Prospective phase II trial with vaginal progesterone as treatment of CIN I and II. 60 patients receive vaginal micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months. After 3 and 6 months patients are examined for possible regression, persistence, or progression of disease and treated accordingly. Treatment of patients with progressing CIN is being discontinued after 3 months. Follow-up of patients is ensured based on current clinical practice, i.e., regular outpatient visits every 3 months, until the lesion completely regresses.
Diagnosis and main inclusion criteria:
CIN I and II diagnosed by punch biopsy, lesion fully visible, otherwise healthy subjects < 60 years, no history of breast cancer, patient's compliance
Medication:
Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
Duration of treatment:
6 months
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- progesterone
- Keywords
- cervical intraepithelial neoplasia (CIN), progesterone
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progesteroneDrug
Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether or not a treatment with vaginal progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months increases regression rates of CIN I and II.
Measured: 6 months
Secondary outcomes (1)
Change of immunohistochemically detected expression of Langerhans Cells in CIN
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startAug 2004
- Primary completionApr 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LHefler, Medical University of Vienna
- Investigators
- Lukas A Hefler, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247169
- Sponsor's protocol ID
- UFK-HEF 4
- Status last verified
- Mar 2012
- First submitted
- 31 Oct 2005
- Last updated
- 9 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial
- ClinicalTrials.gov ID
- NCT00247169
- Acronym / sponsor ID
- UFK-HEF 4
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- cervical intraepithelial neoplasia (CIN), progesterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Nov 2005 (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.
The investigators want to test whether treatment with a natural progesterone intravaginally increases the cure rate of cervical intraepithelial neoplasia grade I and II.
Detailed description
Background:
- The development of cervical intraepithelial neoplasia (CIN) was linked to a decreased local immune response as evidenced by a decrease of Langerhans' cell (LC) count in the cervical epithelium. Preliminary studies show that vaginally administered progesterone locally increases the number of LCs.
- There is no accepted treatment strategy of low grade CIN, i.e., CIN I and II, than await spontaneous regression.
Thus, vaginal progesterone is expected to increase the regression rate of cervical dysplasia grade I and II.
Outcome parameters:
Primary outcome parameters:
To evaluate whether or not a treatment with vaginal progesterone increases regression and remission rates of CIN I and II during a 6-month treatment period.
Secondary outcome parameters:
Change of immunohistochemically detected expression of LCs in CIN.
Methods:
Prospective phase II trial with vaginal progesterone as treatment of CIN I and II. 60 patients receive vaginal micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months. After 3 and 6 months patients are examined for possible regression, persistence, or progression of disease and treated accordingly. Treatment of patients with progressing CIN is being discontinued after 3 months. Follow-up of patients is ensured based on current clinical practice, i.e., regular outpatient visits every 3 months, until the lesion completely regresses.
Diagnosis and main inclusion criteria:
CIN I and II diagnosed by punch biopsy, lesion fully visible, otherwise healthy subjects < 60 years, no history of breast cancer, patient's compliance
Medication:
Micronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25
Duration of treatment:
6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Histological evidence of CIN I and II
- Transformation zone and lesion margins fully visible
- Compliant subject
- Safe contraception
- Negative pregnancy test
Key exclusion criteria (35 listed)
- Lesion related
- CIN III, (micro)-Invasive Cancer
- Endocervical lesion, upper margin of lesion not visible on colposcopy
- Non-compliance of patient
- PAP V
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 |
|---|---|---|
| progesteroneMicronized progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 | Drug | – |
Primary outcome
To evaluate whether or not a treatment with vaginal progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months increases regression rates of CIN I and II.
Time frame: 6 months
1 secondary outcome
Change of immunohistochemically detected expression of Langerhans Cells in CIN
Time frame: 6 months
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 9 Mar 2012.
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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.
Lukas A Hefler, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing progesterone in people with Cervical Intraepithelial Neoplasia, run by Medical University of Vienna at 1 site in Austria.
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 35 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 9 Mar 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 Austria. 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 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?
To evaluate whether or not a treatment with vaginal progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months increases regression rates of CIN I and II. (time frame: 6 months). 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 9 Mar 2012.