EndometriosisNCT00155051
Progestin Treatment for Endometrial Stromal Cells in Adenomyosis
An observational study of Endometriosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Long term treatment of progestin has been demonstrated to have an inhibitory effect on endometrial angiogenesis and the proliferation of endometrial stromal cells. As a result, progestin is now widely employed in the treatment of endometrial cancer, endometrial hyperplasia, and dysfunction uterine bleeding. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2004to Apr 2005
- Phase
- Observational
- 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 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with adenomyosis
- at early- to mid-secretory phases
Who cannot join
- postmenopausal
- malignancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jehn-Hsiahn Yang, M.D., 886-2-2312-3456 ext. 3210, jhyang@ha.mc.ntu.edu.tw
Jehn-Hsiahn Yang, M.D.
About this study
Long term treatment of progestin has been demonstrated to have an inhibitory effect on endometrial angiogenesis and the proliferation of endometrial stromal cells. As a result, progestin is now widely employed in the treatment of endometrial cancer, endometrial hyperplasia, and dysfunction uterine bleeding. In the treatment of adenomyosis, however, the beneficial effect of progestin was limited. It might imply that the behavior of endometrial cells in women with adenomyosis is different from that in women without adenomyosis.
Our previous study revealed that the expression of killer inhibitory receptors (KIRs) on NK cells was decreased in eutopic endometrium in women with adenomyosis. It may be a compensatory effect in which the NK cytotoxicity is activated in order to wipe out the abnormal endometrial cells that might go out of the eutopic site of endometrium. It implies that the formation of adenomyosis might be due to "abnormal" endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. This finding is compatible with previous reports in which eutopic endometrium obtained from women with endometriosis or adenomyosis was found to behave differently from endometrium in unaffected women.
In this study, we try to collect endometrial tissues from women with and without adenomyosis, and then purify the endometrial stromal cells from endometrium. The endometrial stromal cells are cultured for 8 days with the supplement of medroxyprogesterone (MPA) or danazol. Quantification of IL-6 and IL-8 mRNA in endometrial cells, and the concentrations of IL-6 and IL-8 in cultured media will be done with real time RT-PCR and ELISA respectively. The expression of different cytokines of endometrial cells in response to progestin might be further elucidated after our experiment.
Read the detailed description
Eutopic endometrium was obtained and separated into single endometrial stromal cell (ESC) in women with adenomyosis (study group) and without adenomyosis (control group).
After becoming pre-confluent (covering 80% of the culture well), ESC was cultured for 8 days solely or with the addition of medroxyprogesterone (MPA) or danazol.
ELISA was done to measure IL-6, IL-8, and TNF-alpha concentrations of the culture media.
Real-time quantitative RT-PCR was done to measure IL-6, IL-8, and TNF-alpha RNA levels in ESC.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jehn-Hsiahn Yang, M.D., Principal investigator, Department of Obstetrics and Gynecology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155051
- Sponsor's protocol ID
- 9361700762
- Other IDs
- NTUH.94S72
- Status last verified
- Jun 2004
- First submitted
- 9 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progestin Treatment for Endometrial Stromal Cells in Adenomyosis
- ClinicalTrials.gov ID
- NCT00155051
- Acronym / sponsor ID
- 9361700762
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2004
- Study completion
- Apr 2005
- First posted
- 12 Sep 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.
Long term treatment of progestin has been demonstrated to have an inhibitory effect on endometrial angiogenesis and the proliferation of endometrial stromal cells. As a result, progestin is now widely employed in the treatment of endometrial cancer, endometrial hyperplasia, and dysfunction uterine bleeding. In the treatment of adenomyosis, however, the beneficial effect of progestin was limited. It might imply that the behavior of endometrial cells in women with adenomyosis is different from that in women without adenomyosis.
Our previous study revealed that the expression of killer inhibitory receptors (KIRs) on NK cells was decreased in eutopic endometrium in women with adenomyosis. It may be a compensatory effect in which the NK cytotoxicity is activated in order to wipe out the abnormal endometrial cells that might go out of the eutopic site of endometrium. It implies that the formation of adenomyosis might be due to "abnormal" endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. This finding is compatible with previous reports in which eutopic endometrium obtained from women with endometriosis or adenomyosis was found to behave differently from endometrium in unaffected women.
In this study, we try to collect endometrial tissues from women with and without adenomyosis, and then purify the endometrial stromal cells from endometrium. The endometrial stromal cells are cultured for 8 days with the supplement of medroxyprogesterone (MPA) or danazol. Quantification of IL-6 and IL-8 mRNA in endometrial cells, and the concentrations of IL-6 and IL-8 in cultured media will be done with real time RT-PCR and ELISA respectively. The expression of different cytokines of endometrial cells in response to progestin might be further elucidated after our experiment.
Detailed description
Eutopic endometrium was obtained and separated into single endometrial stromal cell (ESC) in women with adenomyosis (study group) and without adenomyosis (control group).
After becoming pre-confluent (covering 80% of the culture well), ESC was cultured for 8 days solely or with the addition of medroxyprogesterone (MPA) or danazol.
ELISA was done to measure IL-6, IL-8, and TNF-alpha concentrations of the culture media.
Real-time quantitative RT-PCR was done to measure IL-6, IL-8, and TNF-alpha RNA levels in ESC.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women with adenomyosis
- at early- to mid-secretory phases
Key exclusion criteria (2 listed)
- postmenopausal
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Jehn-Hsiahn Yang, M.D. principal investigator
Department of Obstetrics and Gynecology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Sep 2005. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jehn-Hsiahn Yang, M.D. (886-2-2312-3456 ext. 3210, jhyang@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 12 Sep 2005.