EndometriosisNCT03778359
Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis
An observational study of Endometriosis and Adenomyosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Endometriosis (including adenomyosis) is one of the most common gynecological diseases among women of childbearing age. Common symptoms such as menstrual pain, excessive menstrual flow, infertility, chronic lower abdominal pain, and painful intercourse. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis, Adenomyosis
- What is being tested?
- Leuprorelin, Levonorgestrel and Dienogest
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 5,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2005to 18 Oct 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects were patients who underwent endometriosis and adenomyosis-related surgery at Taipei Veterans General Hospital from 2005 to 2018. Review the surgical records and related medical records and record the follow-up medications received by the patients. The procedure includes traditional open or endoscopic ovarian cyst resection, oophorectomy, and lesion resection; open abdominal, transvaginal or endoscopic assisted transvaginal hysterectomy, open or endoscopic adenoma, gland Myomectomy. Postoperative patients received medication such as GnRH agonist, Levonorgestrel-releasing intrauterine system (LNG-IUS), hormonal preparation (danazol, gestrinone, oral lutein), oral Oral contraceptive, and tracking the size of the lesion with ultrasound, analyzing the patient's clinical prognosis, pain, side effects and tolerance, follow-up pregnancy and production, the
Who may be able to join
- Patients who underwent endometriosis or adenomyosis-related surgery in the investigator's hospital from 2005/01/01 to 2018/12/31, and received follow-up medication.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Endometriosis (including adenomyosis) is one of the most common gynecological diseases among women of childbearing age. Common symptoms such as menstrual pain, excessive menstrual flow, infertility, chronic lower abdominal pain, and painful intercourse. According to the literature statistics, the prevalence of endometriosis in women of childbearing age is about 10-20%, while the prevalence of adenomyosis is about 5%. Traditional medical treatments include hormones (danazol, gestrinone, oral lutein). Oral contraceptive, there is a Gonadotropin-releasing hormone agonist in the injection form, and a levonorgestrel-releasing intrauterine system in the intrauterine administration system. The choice of drugs has many influencing factors, such as the severity of endometriosis in patients (according to the classification of the American Society for Reproductive Medicine), the need for fertility, the convenience of drug use, and the patient's tolerance to drug side effects. Surgery is also one of the treatment options for endometriosis and adenomyosis, including traditional open or minimally invasive endoscopic ovarian cyst resection, oophorectomy, and lesion resection; adenomyosis surgery includes traditional methods Open abdominal, transvaginal or minimally invasive endoscopic hysterectomy, conservative uterine sparing adenomyomectomy and cytoreduction surgery (partial adenomyomectomy). For endometriosis, the common treatment consensus of obstetricians and gynecologists is to follow the surgical treatment of the lesions and then follow-up medication. For women with adenomyosis, if they have completed the birth, it is recommended to have a total hysterectomy, so that there is no recurrence. The possibility. However, for women who have not completed birth, conservative uterine preservation surgery is performed. According to research statistics, endometriosis or adenomyosis does not receive follow-up medical treatment after completion of surgical treatment, there is a high probability of recurrence, but the side effects caused by drugs will also affect the patient's compliance with medication.The Department of Women's Medicine of the hospital has a wealth of experience in the treatment of endometriosis and adenomyosis. Each year, about 500 cases of endometriosis (including adenomyosis) are performed. This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments.
Read the detailed description
The main purpose: to analyze the prognosis and treatment effect of endometriosis and adenomyosis after surgery and drug treatment.
Secondary objective: Analysis of endometriosis and adenomyosis after surgery and medication, the patient's assessment of drug side effects.
- Conditions
- Endometriosis, Adenomyosis
- Being tested
- Leuprorelin, Levonorgestrel, Dienogest, Progestins
- Medical subject headings
- Endometriosis, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprorelinDrug
This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Leuprorelin.
LevonorgestrelDevice
This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Levonorgestrel.
DienogestDrug
This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Dienogest.
ProgestinsDrug
This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Progestins.
| Study group | Role | What they receive |
|---|---|---|
| Gonadotropin-releasing hormone agonist treatment | Endometriosis post-operative Gonadotropin-releasing hormone agonist treatment Receives: Drug: Leuprorelin | |
| Intrauterine device treatment | Endometriosis post-operative intrauterine device treatment Receives: Device: Levonorgestrel | |
| Hormone therapy | Endometriosis post-operative hormone therapy Receives: Drug: Dienogest | |
| Oral contraceptive | Endometriosis post-operative oral contraceptive Receives: Drug: Progestins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain before and after surgery
Visual analogue scale ranges from 0 to 10 points, with higher scores indicative of more pain. We measure it before the surgery and follow it after intervention one month, three months and six months seperately.
Measured: 01/2005~12/2015
Secondary outcomes (3)
Hemoglobin
Preoperative serum hemoglobin levels were measured in women diagnosed by ultrasound or with endometriosis, adenomyosis, leiomyomas. We also follow up after intervention one month, three months and six months seperately.
The normal value is range 12-15g/dl.
Measured: 01/2005~12/2015
Tumor marker (CA-125)
Preoperative serum CA-125 levels were measured in women diagnosed by ultrasound or with endometriosis, adenomyosis, leiomyomas. We also follow up after intervention one month, three months and six months seperately. The normal value is less than 35 U/mL.
Measured: 01/2005~12/2015
Ultrasound image tracking
Ovary endoemtriosis definition : Well-circumscribed thick-walled unilocular cyst that contains homogeneous low-level internal echoes ground glass. We measure it according to guideline Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms,definitions and measurements: a consensus opinion from theInternational Deep Endometriosis Analysis (IDEA) group Adenomyosis definition : Asymmetrical myometrial thickening Globular shape, ill defined endometrial/ myometrial interface and linear striations. We measure it according to guideline Systematic approach to sonographic evaluation of the pelvisin women with suspected endometriosis, including terms,definitions and measurements: a consensus opinion from theInternational Deep Endometriosis Analysis (IDEA) group
Measured: 01/2005~12/2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2005
- Primary completion31 Dec 2015
- Study completion18 Oct 2018
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 Taipei Veterans General Hospital, TaiwanThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Peng-Hui Wang, MD, PhD, Study chair, pongpongwang@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778359
- Sponsor's protocol ID
- 2017-10-012AC
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis
- ClinicalTrials.gov ID
- NCT03778359
- Acronym / sponsor ID
- 2017-10-012AC
- Conditions
- Endometriosis, Adenomyosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 19 Dec 2018 (actual)
- 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.
Endometriosis (including adenomyosis) is one of the most common gynecological diseases among women of childbearing age. Common symptoms such as menstrual pain, excessive menstrual flow, infertility, chronic lower abdominal pain, and painful intercourse. According to the literature statistics, the prevalence of endometriosis in women of childbearing age is about 10-20%, while the prevalence of adenomyosis is about 5%. Traditional medical treatments include hormones (danazol, gestrinone, oral lutein). Oral contraceptive, there is a Gonadotropin-releasing hormone agonist in the injection form, and a levonorgestrel-releasing intrauterine system in the intrauterine administration system. The choice of drugs has many influencing factors, such as the severity of endometriosis in patients (according to the classification of the American Society for Reproductive Medicine), the need for fertility, the convenience of drug use, and the patient's tolerance to drug side effects. Surgery is also one of the treatment options for endometriosis and adenomyosis, including traditional open or minimally invasive endoscopic ovarian cyst resection, oophorectomy, and lesion resection; adenomyosis surgery includes traditional methods Open abdominal, transvaginal or minimally invasive endoscopic hysterectomy, conservative uterine sparing adenomyomectomy and cytoreduction surgery (partial adenomyomectomy). For endometriosis, the common treatment consensus of obstetricians and gynecologists is to follow the surgical treatment of the lesions and then follow-up medication. For women with adenomyosis, if they have completed the birth, it is recommended to have a total hysterectomy, so that there is no recurrence. The possibility. However, for women who have not completed birth, conservative uterine preservation surgery is performed. According to research statistics, endometriosis or adenomyosis does not receive follow-up medical treatment after completion of surgical treatment, there is a high probability of recurrence, but the side effects caused by drugs will also affect the patient's compliance with medication.The Department of Women's Medicine of the hospital has a wealth of experience in the treatment of endometriosis and adenomyosis. Each year, about 500 cases of endometriosis (including adenomyosis) are performed. This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments.
Detailed description
The main purpose: to analyze the prognosis and treatment effect of endometriosis and adenomyosis after surgery and drug treatment.
Secondary objective: Analysis of endometriosis and adenomyosis after surgery and medication, the patient's assessment of drug side effects.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gonadotropin-releasing hormone agonist treatment | – | Drug: LeuprorelinEndometriosis post-operative Gonadotropin-releasing hormone agonist treatment |
| Intrauterine device treatment | – | Device: LevonorgestrelEndometriosis post-operative intrauterine device treatment |
| Hormone therapy | – | Drug: DienogestEndometriosis post-operative hormone therapy |
| Oral contraceptive | – | Drug: ProgestinsEndometriosis post-operative oral contraceptive |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects were patients who underwent endometriosis and adenomyosis-related surgery at Taipei Veterans General Hospital from 2005 to 2018. Review the surgical records and related medical records and record the follow-up medications received by the patients. The procedure includes traditional open or endoscopic ovarian cyst resection, oophorectomy, and lesion resection; open abdominal, transvaginal or endoscopic assisted transvaginal hysterectomy, open or endoscopic adenoma, gland Myomectomy. Postoperative patients received medication such as GnRH agonist, Levonorgestrel-releasing intrauterine system (LNG-IUS), hormonal preparation (danazol, gestrinone, oral lutein), oral Oral contraceptive, and tracking the size of the lesion with ultrasound, analyzing the patient's clinical prognosis, pain, side effects and tolerance, follow-up pregnancy and production, the
Key inclusion criteria (1 listed)
- Patients who underwent endometriosis or adenomyosis-related surgery in the investigator's hospital from 2005/01/01 to 2018/12/31, and received follow-up medication.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| LeuprorelinThis study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Leuprorelin. | Drug | Gonadotropin-releasing hormone agonist treatment |
| LevonorgestrelThis study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Levonorgestrel. | Device | Intrauterine device treatment |
| DienogestThis study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Dienogest. | Drug | Hormone therapy |
| ProgestinsThis study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Progestins. | Drug | Oral contraceptive |
Primary outcome
Pain before and after surgery
Time frame: 01/2005~12/2015
Visual analogue scale ranges from 0 to 10 points, with higher scores indicative of more pain. We measure it before the surgery and follow it after intervention one month, three months and six months seperately.
3 secondary outcomes
Hemoglobin
Time frame: 01/2005~12/2015
Tumor marker (CA-125)
Time frame: 01/2005~12/2015
Ultrasound image tracking
Time frame: 01/2005~12/2015
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 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Peng-Hui Wang, MD, PhD study chair
pongpongwang@gmail.com
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 and Adenomyosis, run by Taipei Veterans General Hospital, Taiwan 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 1 inclusion and 1 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 Dec 2018. 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?
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?
Pain before and after surgery (time frame: 01/2005~12/2015). 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 Dec 2018.