Endometrial HyperplasiaPhase 4MirenaNCT01074892
A Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia
A Phase 4 study testing Provera (medroxyprogesterone/progestin), Provera (medroxyprogesterone) and Mirena (levonorgestrel) in people with Endometrial Hyperplasia, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Randomized controlled multi-center study with three arms including 200 patients with low risk endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the following treatments: 1. Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10 day each cycle, 2. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Endometrial Hyperplasia
- What is being tested?
- Provera (medroxyprogesterone/progestin), Provera (medroxyprogesterone) and Mirena (levonorgestrel)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNorway
- Study dates
- May 2005to Dec 2013
- Phase
- Phase 4
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed endometrial hyperplasia,
- D-score > 0,
- Age 30-70 years,
- No contra-indications against progestin hormones,
- Written consent,
- Patients who have been treated with transcervical resection need a histologically confirmed diagnosis of hyperplasia taken after the TCR
Who cannot join
- D-score < 0,
- Age < 30 or > 70,
- Increased sensitivity to progestins,
- Pregnancy,
- Infection or cancer in genitalia or mammary gland,
- Liver disease,
- Serious thrombophlebitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia
Randomized controlled multi-center study with three arms including 200 patients with low risk endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the following treatments:
- Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10 day each cycle,
- MPA 10 mg continuously for 6 months,
- Mirena (Levonorgestrel) impregnated IUD for 6 months.
Read the detailed description
Background:
Endometrial cancer is the most common gynecologic cancer in the Western world and the incidence is still increasing. Endometrial cancer is principally developing through preliminary stages called endometrial hyperplasia and 10-30 per cent will develop into carcinoma when left untreated. The incidence of endometrial cancer in Norway is presently about 650 cases per year and about 3000 cases of endometrial hyperplasia are estimated. Thus,correct and optimal treatment of endometrial hyperplasia will contribute to prevent endometrial cancer development and also in the long term, to reduce the incidence of endometrial cancer. Correct treatment of endometrial hyperplasia includes operative treatment with hysterectomy of the high risk cases and conservative treatment and follow up for patients with lower risk. As diagnostics of endometrial hyperplasia has been a challenge to pathologists, overtreatment of patients with low risk of cancer development is unfortunately still a problem. In the present study an objective scoring system, D-score, is used to classify the patients into low and high risk hyperplasia. D-score in an objective morphometric analysis and the scoring system has proved reliable to predict the prognosis of each single case as to cancer development or not. By tradition low risk endometrial hyperplasia is treated conservatively with progestin hormones, however, no national routines really exist according to dose, type of progestin, treatment time or distribution route, however, varying doses of per oral treatment is mostly used.
Progestins hormones are known to have a growth regulatory effect on the uterine mucosa. However, treatment success after per oral therapy has shown that up to 50% are non-responders after per oral treatment. On the other hand a few recent studies have reported successful results after using the LNG-IUD as treatment for endometrial hyperplasia with 100 per cent treatment response.
The levonorgestrel impregnated impregnated intrauterine originally constructed for menorrhagia and contraceptive use, is delivering more than hundred times increased concentration of progesterone to the uterine mucosa compared to per oral therapy. Thus , the favourable treatment is attributable to the increased concentration of progestins obtained in the uterine mucosa. Another advantage is that treatment can last for years and that side-effects seen for per oral treatment after progestin therapy can be avoided.
Inclusion:
Most of the patients in the present study are seeing their gynecologist due to irregular bleedings.Biopsy is routinely taken by the gynecologist to exclude malignancy or verify hyperplasia. The biopsy is investigated routinely by a the local pathologist. If the diagnosis of hyperplasia is verified and the patient fulfils the inclusion criteria, the histological specimen is sent to the laboratory in Tromsø for D-score. When D-score is >0, the patient may be included in the study.
D-score:
The D-score system is dividing the patients into three risk groups:
- Patients having a D-score <0 are shown to have a high risk of cancer development are recommended hysterectomy.
- Patients having D-score >1 have very low risk of cancer development and are recommended progestin treatment.
- Patients having D-score 0-1 have an uncertain risk of cancer development and may be treated conservatively. Only patients with D-score > 0 may be included in the study.
Randomization:
When the gynecologist receive the diagnosis and the D-score results and the D-score is in accordance with the inclusion criteria, the patients is asked by her gynecologist to be included in the study.
If consent is given, the randomization is performed by telephone contact with the randomization office , UNN, Tromsø, after written informed consent. The patient is free to leave the study any time without argument.
Treatment:
After randomization the treatment according to assigned treatment arm can be started. During the therapy period the patient will be controlled with repeat biopsy after 3 months and at the end of treatment after 6 months. D-score is repeated if hyperplasia persists. If a negative D-score is performed, the patient will have to leave the study. If D-score is still positive the patient will also leave the study, new therapy is then decided by the local gynecologist.
Control:
All patients will be controlled with repeat biopsy every six month for two years after end of therapy. If recurrence of hyperplasia occurs the patient will leave the study and receive other therapy decided by her own gynecologist after repeated D-score.
Side effects:
All side effects which can be related to treatment during treatment and/or follow-up will be reported.
- Conditions
- Endometrial Hyperplasia
- Being tested
- Provera (medroxyprogesterone/progestin), Provera (medroxyprogesterone), Mirena (levonorgestrel)
- Keywords
- endometrial hyperplasia treatment MPA per os LNG-IUD
- Medical subject headings
- Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provera (medroxyprogesterone/progestin)Drug
Also called Provera
10 mg tablet, 1 tablet per day taken 10 days per month Duration is 6 months
Provera (medroxyprogesterone)Drug
Also called Provera
10 mg per oral tablet. One tablet per day for 6 months
Mirena (levonorgestrel)Device
Also called Mirena
Inserted in the uterine cavity and kept in situ for 6 months
| Study group | Role | What they receive |
|---|---|---|
| MPA 10 mg per oral cyclic for 6 months | Active comparator | The peroral treatment is used 10 days each month Receives: Drug: Provera (medroxyprogesterone/progestin) |
| MPA 10 mg per os continuous 6 months | Active comparator | Per oral MPA 10 mg is taken daily for 6 months Receives: Drug: Provera (medroxyprogesterone) |
| LNG-IUD for 6 months | Active comparator | Levonorgestrel impregnated IUD is inserted into the uterine cavity and kept in situ for 6 months Receives: Device: Mirena (levonorgestrel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of hyperplasia related to treatment arm after 6 months of therapy
Measured: Six months
Secondary outcomes (2)
Recurrence of hyperplasia related to treatment arm during follow-up period
Measured: Two years
Side effects during treatment
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startMay 2005
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Endometrial HyperplasiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord, Norwegian Cancer Society
- Responsible party
- Sponsor
- Investigators
- Anne Ørbo, MD, PhD, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074892
- Sponsor's protocol ID
- REK nr 25/2004
- Acronym
- Mirena
- Status last verified
- May 2012
- First submitted
- 23 Feb 2010
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kurman RJ, Kaminski PF, Norris HJ. The behavior of endometrial hyperplasia. A long-term study of "untreated" hyperplasia in 170 patients. Cancer. 1985 Jul 15;56(2):403-12. doi: 10.1002/1097-0142(19850715)56:23.0.co;2-x.
PubMed 4005805Ferenczy A, Gelfand M. The biologic significance of cytologic atypia in progestogen-treated endometrial hyperplasia. Am J Obstet Gynecol. 1989 Jan;160(1):126-31. doi: 10.1016/0002-9378(89)90103-8.
PubMed 2912075Orbo A, Baak JP, Kleivan I, Lysne S, Prytz PS, Broeckaert MA, Slappendel A, Tichelaar HJ. Computerised morphometrical analysis in endometrial hyperplasia for the prediction of cancer development. A long-term retrospective study from northern Norway. J Clin Pathol. 2000 Sep;53(9):697-703. doi: 10.1136/jcp.53.9.697.
PubMed 11041060Vereide AB, Arnes M, Straume B, Maltau JM, Orbo A. Nuclear morphometric changes and therapy monitoring in patients with endometrial hyperplasia: a study comparing effects of intrauterine levonorgestrel and systemic medroxyprogesterone. Gynecol Oncol. 2003 Dec;91(3):526-33. doi: 10.1016/j.ygyno.2003.07.002.
PubMed 14675671Nilsson CG, Haukkamaa M, Vierola H, Luukkainen T. Tissue concentrations of levonorgestrel in women using a levonorgestrel-releasing IUD. Clin Endocrinol (Oxf). 1982 Dec;17(6):529-36. doi: 10.1111/j.1365-2265.1982.tb01625.x.
PubMed 6819901Scarselli G, Tantini C, Colafranceschi M, Taddei GL, Bargelli G, Venturini N, Branconi F. Levo-norgestrel-nova-T and precancerous lesions of the endometrium. Eur J Gynaecol Oncol. 1988;9(4):284-6.
PubMed 3391204Orbo A, Arnes M, Hancke C, Vereide AB, Pettersen I, Larsen K. Treatment results of endometrial hyperplasia after prospective D-score classification: a follow-up study comparing effect of LNG-IUD and oral progestins versus observation only. Gynecol Oncol. 2008 Oct;111(1):68-73. doi: 10.1016/j.ygyno.2008.06.014. Epub 2008 Aug 6.
PubMed 18684496Baak JP, Nauta JJ, Wisse-Brekelmans EC, Bezemer PD. Architectural and nuclear morphometrical features together are more important prognosticators in endometrial hyperplasias than nuclear morphometrical features alone. J Pathol. 1988 Apr;154(4):335-41. doi: 10.1002/path.1711540409.
PubMed 3385513Perino A, Quartararo P, Catinella E, Genova G, Cittadini E. Treatment of endometrial hyperplasia with levonorgestrel releasing intrauterine devices. Acta Eur Fertil. 1987 Mar-Apr;18(2):137-40.
PubMed 3115027Vereide AB, Kaino T, Sager G, Orbo A; Scottish Gynaecological Clinical Trials Group. Bcl-2, BAX, and apoptosis in endometrial hyperplasia after high dose gestagen therapy: a comparison of responses in patients treated with intrauterine levonorgestrel and systemic medroxyprogesterone. Gynecol Oncol. 2005 Jun;97(3):740-50. doi: 10.1016/j.ygyno.2005.02.030.
PubMed 15885761Vereide AB, Kaino T, Sager G, Arnes M, Orbo A. Effect of levonorgestrel IUD and oral medroxyprogesterone acetate on glandular and stromal progesterone receptors (PRA and PRB), and estrogen receptors (ER-alpha and ER-beta) in human endometrial hyperplasia. Gynecol Oncol. 2006 May;101(2):214-23. doi: 10.1016/j.ygyno.2005.10.030. Epub 2005 Dec 1.
PubMed 16325240Moe BT, Vereide AB, Orbo A, Jaeger R, Sager G. Levonorgestrel, medroxyprogesterone and progesterone cause a concentration-dependent reduction in endometrial cancer (Ishikawa) cell density, and high concentrations of progesterone and mifepristone act in synergy. Anticancer Res. 2009 Apr;29(4):1047-52.
PubMed 19414344Mittermeier T, Farrant C, Wise MR. Levonorgestrel-releasing intrauterine system for endometrial hyperplasia. Cochrane Database Syst Rev. 2020 Sep 6;9(9):CD012658. doi: 10.1002/14651858.CD012658.pub2.
PubMed 32909630Orbo A, Vereide A, Arnes M, Pettersen I, Straume B. Levonorgestrel-impregnated intrauterine device as treatment for endometrial hyperplasia: a national multicentre randomised trial. BJOG. 2014 Mar;121(4):477-86. doi: 10.1111/1471-0528.12499. Epub 2013 Nov 28.
PubMed 24286192
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia
- ClinicalTrials.gov ID
- NCT01074892
- Acronym / sponsor ID
- Mirena / REK nr 25/2004
- Conditions
- Endometrial Hyperplasia
- Keywords
- endometrial hyperplasia treatment MPA per os LNG-IUD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Helse Nord, Norwegian Cancer Society
- Study start
- May 2005
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Feb 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.
Randomized controlled multi-center study with three arms including 200 patients with low risk endometrial hyperplasia. After confirmed diagnosis the patients will receive one of the following treatments:
- Provera (Medroxyprogesterone (MPA)/progestin) 10 mg per oral treatment for 6 months 10 day each cycle,
- MPA 10 mg continuously for 6 months,
- Mirena (Levonorgestrel) impregnated IUD for 6 months.
Detailed description
Background:
Endometrial cancer is the most common gynecologic cancer in the Western world and the incidence is still increasing. Endometrial cancer is principally developing through preliminary stages called endometrial hyperplasia and 10-30 per cent will develop into carcinoma when left untreated. The incidence of endometrial cancer in Norway is presently about 650 cases per year and about 3000 cases of endometrial hyperplasia are estimated. Thus,correct and optimal treatment of endometrial hyperplasia will contribute to prevent endometrial cancer development and also in the long term, to reduce the incidence of endometrial cancer. Correct treatment of endometrial hyperplasia includes operative treatment with hysterectomy of the high risk cases and conservative treatment and follow up for patients with lower risk. As diagnostics of endometrial hyperplasia has been a challenge to pathologists, overtreatment of patients with low risk of cancer development is unfortunately still a problem. In the present study an objective scoring system, D-score, is used to classify the patients into low and high risk hyperplasia. D-score in an objective morphometric analysis and the scoring system has proved reliable to predict the prognosis of each single case as to cancer development or not. By tradition low risk endometrial hyperplasia is treated conservatively with progestin hormones, however, no national routines really exist according to dose, type of progestin, treatment time or distribution route, however, varying doses of per oral treatment is mostly used.
Progestins hormones are known to have a growth regulatory effect on the uterine mucosa. However, treatment success after per oral therapy has shown that up to 50% are non-responders after per oral treatment. On the other hand a few recent studies have reported successful results after using the LNG-IUD as treatment for endometrial hyperplasia with 100 per cent treatment response.
The levonorgestrel impregnated impregnated intrauterine originally constructed for menorrhagia and contraceptive use, is delivering more than hundred times increased concentration of progesterone to the uterine mucosa compared to per oral therapy. Thus , the favourable treatment is attributable to the increased concentration of progestins obtained in the uterine mucosa. Another advantage is that treatment can last for years and that side-effects seen for per oral treatment after progestin therapy can be avoided.
Inclusion:
Most of the patients in the present study are seeing their gynecologist due to irregular bleedings.Biopsy is routinely taken by the gynecologist to exclude malignancy or verify hyperplasia. The biopsy is investigated routinely by a the local pathologist. If the diagnosis of hyperplasia is verified and the patient fulfils the inclusion criteria, the histological specimen is sent to the laboratory in Tromsø for D-score. When D-score is >0, the patient may be included in the study.
D-score:
The D-score system is dividing the patients into three risk groups:
- Patients having a D-score <0 are shown to have a high risk of cancer development are recommended hysterectomy.
- Patients having D-score >1 have very low risk of cancer development and are recommended progestin treatment.
- Patients having D-score 0-1 have an uncertain risk of cancer development and may be treated conservatively. Only patients with D-score > 0 may be included in the study.
Randomization:
When the gynecologist receive the diagnosis and the D-score results and the D-score is in accordance with the inclusion criteria, the patients is asked by her gynecologist to be included in the study.
If consent is given, the randomization is performed by telephone contact with the randomization office , UNN, Tromsø, after written informed consent. The patient is free to leave the study any time without argument.
Treatment:
After randomization the treatment according to assigned treatment arm can be started. During the therapy period the patient will be controlled with repeat biopsy after 3 months and at the end of treatment after 6 months. D-score is repeated if hyperplasia persists. If a negative D-score is performed, the patient will have to leave the study. If D-score is still positive the patient will also leave the study, new therapy is then decided by the local gynecologist.
Control:
All patients will be controlled with repeat biopsy every six month for two years after end of therapy. If recurrence of hyperplasia occurs the patient will leave the study and receive other therapy decided by her own gynecologist after repeated D-score.
Side effects:
All side effects which can be related to treatment during treatment and/or follow-up will be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MPA 10 mg per oral cyclic for 6 months | Active comparator | Drug: Provera (medroxyprogesterone/progestin)The peroral treatment is used 10 days each month |
| MPA 10 mg per os continuous 6 months | Active comparator | Drug: Provera (medroxyprogesterone)Per oral MPA 10 mg is taken daily for 6 months |
| LNG-IUD for 6 months | Active comparator | Device: Mirena (levonorgestrel)Levonorgestrel impregnated IUD is inserted into the uterine cavity and kept in situ for 6 months |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed endometrial hyperplasia,
- D-score > 0,
- Age 30-70 years,
- No contra-indications against progestin hormones,
- Written consent,
Key exclusion criteria (7 listed)
- D-score < 0,
- Age < 30 or > 70,
- Increased sensitivity to progestins,
- Pregnancy,
- Infection or cancer in genitalia or mammary gland,
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 |
|---|---|---|
| Provera (medroxyprogesterone/progestin)Also: Provera10 mg tablet, 1 tablet per day taken 10 days per month Duration is 6 months | Drug | MPA 10 mg per oral cyclic for 6 months |
| Provera (medroxyprogesterone)Also: Provera10 mg per oral tablet. One tablet per day for 6 months | Drug | MPA 10 mg per os continuous 6 months |
| Mirena (levonorgestrel)Also: MirenaInserted in the uterine cavity and kept in situ for 6 months | Device | LNG-IUD for 6 months |
Primary outcome
Regression of hyperplasia related to treatment arm after 6 months of therapy
Time frame: Six months
2 secondary outcomes
Recurrence of hyperplasia related to treatment arm during follow-up period
Time frame: Two years
Side effects during treatment
Time frame: Two years
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 5 Apr 2019.
- Background: PubMed 4005805Kurman RJ, Kaminski PF, Norris HJ. The behavior of endometrial hyperplasia. A long-term study of "untreated" hyperplasia in 170 patients. Cancer. 1985 Jul 15;56(2):403-12. doi: 10.1002/1097-0142(19850715)56:23.0.co;2-x.
- Background: PubMed 2912075Ferenczy A, Gelfand M. The biologic significance of cytologic atypia in progestogen-treated endometrial hyperplasia. Am J Obstet Gynecol. 1989 Jan;160(1):126-31. doi: 10.1016/0002-9378(89)90103-8.
- Background: PubMed 11041060Orbo A, Baak JP, Kleivan I, Lysne S, Prytz PS, Broeckaert MA, Slappendel A, Tichelaar HJ. Computerised morphometrical analysis in endometrial hyperplasia for the prediction of cancer development. A long-term retrospective study from northern Norway. J Clin Pathol. 2000 Sep;53(9):697-703. doi: 10.1136/jcp.53.9.697.
- Background: PubMed 14675671Vereide AB, Arnes M, Straume B, Maltau JM, Orbo A. Nuclear morphometric changes and therapy monitoring in patients with endometrial hyperplasia: a study comparing effects of intrauterine levonorgestrel and systemic medroxyprogesterone. Gynecol Oncol. 2003 Dec;91(3):526-33. doi: 10.1016/j.ygyno.2003.07.002.
- Background: PubMed 6819901Nilsson CG, Haukkamaa M, Vierola H, Luukkainen T. Tissue concentrations of levonorgestrel in women using a levonorgestrel-releasing IUD. Clin Endocrinol (Oxf). 1982 Dec;17(6):529-36. doi: 10.1111/j.1365-2265.1982.tb01625.x.
- Background: PubMed 3391204Scarselli G, Tantini C, Colafranceschi M, Taddei GL, Bargelli G, Venturini N, Branconi F. Levo-norgestrel-nova-T and precancerous lesions of the endometrium. Eur J Gynaecol Oncol. 1988;9(4):284-6.
- Background: PubMed 18684496Orbo A, Arnes M, Hancke C, Vereide AB, Pettersen I, Larsen K. Treatment results of endometrial hyperplasia after prospective D-score classification: a follow-up study comparing effect of LNG-IUD and oral progestins versus observation only. Gynecol Oncol. 2008 Oct;111(1):68-73. doi: 10.1016/j.ygyno.2008.06.014. Epub 2008 Aug 6.
- Background: PubMed 3385513Baak JP, Nauta JJ, Wisse-Brekelmans EC, Bezemer PD. Architectural and nuclear morphometrical features together are more important prognosticators in endometrial hyperplasias than nuclear morphometrical features alone. J Pathol. 1988 Apr;154(4):335-41. doi: 10.1002/path.1711540409.
- Background: PubMed 3115027Perino A, Quartararo P, Catinella E, Genova G, Cittadini E. Treatment of endometrial hyperplasia with levonorgestrel releasing intrauterine devices. Acta Eur Fertil. 1987 Mar-Apr;18(2):137-40.
- Background: PubMed 15885761Vereide AB, Kaino T, Sager G, Orbo A; Scottish Gynaecological Clinical Trials Group. Bcl-2, BAX, and apoptosis in endometrial hyperplasia after high dose gestagen therapy: a comparison of responses in patients treated with intrauterine levonorgestrel and systemic medroxyprogesterone. Gynecol Oncol. 2005 Jun;97(3):740-50. doi: 10.1016/j.ygyno.2005.02.030.
- Background: PubMed 16325240Vereide AB, Kaino T, Sager G, Arnes M, Orbo A. Effect of levonorgestrel IUD and oral medroxyprogesterone acetate on glandular and stromal progesterone receptors (PRA and PRB), and estrogen receptors (ER-alpha and ER-beta) in human endometrial hyperplasia. Gynecol Oncol. 2006 May;101(2):214-23. doi: 10.1016/j.ygyno.2005.10.030. Epub 2005 Dec 1.
- Background: PubMed 19414344Moe BT, Vereide AB, Orbo A, Jaeger R, Sager G. Levonorgestrel, medroxyprogesterone and progesterone cause a concentration-dependent reduction in endometrial cancer (Ishikawa) cell density, and high concentrations of progesterone and mifepristone act in synergy. Anticancer Res. 2009 Apr;29(4):1047-52.
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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.
Anne Ørbo, MD, PhD principal investigator
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Provera (medroxyprogesterone/progestin), Provera (medroxyprogesterone) and Mirena (levonorgestrel) in people with Endometrial Hyperplasia, run by University Hospital of North Norway at 1 site in Norway.
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 6 inclusion and 7 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 5 Apr 2019. 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 Norway. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Regression of hyperplasia related to treatment arm after 6 months of therapy (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074892, which also lists 14 linked publications.
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 5 Apr 2019.