EndometriosisPhase 4NCT02427386
Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis
A Phase 4 study testing dynamized estrogen in people with Endometriosis and Pelvic Pain, run by University of Sao Paulo General Hospital.
Trial summary
Endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat. In view of this, many patients seek assistance in complementary and alternative medicine, including homeopathic treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Pelvic Pain
- What is being tested?
- dynamized estrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2016
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- primary inclusion criteria:
- aged between 18 and 45;
- diagnosis of endometriosis (endometrial ectopia) confirmed by imaging test (MRI or TVUS) or laparoscopy (biopsy);
- chronic pelvic pain refractory to conventional hormone treatments and with intensity ≥ 5 on the visual analog pain scale (VAS-Pain: 0-10 points);
- secondary inclusion criteria:
- symptomatic individualization of patients according to adverse events of estrogen (minimum syndrome of maximum value).
Who cannot join
- absence of clinical and laboratory diagnosis of menopause or
- premature ovarian failure
About this study
Official title: Phase 4 Randomized Controlled Trial of Dynamized Estrogen in Individualized Homeopathic Treatment of Chronic Pelvic Pain of Endometriosis
Endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat. In view of this, many patients seek assistance in complementary and alternative medicine, including homeopathic treatment. The absence of evidence in the literature raises controversy about the effectiveness of homeopathic treatment in endometriosis. The aim of this randomized trial is to evaluate the effectiveness of dynamized estrogen compared to placebo in the treatment of chronic pelvic pain of endometriosis.
Read the detailed description
This is a randomized, double-blind and placebo controlled trial using individualised homeopathic medicine (dynamized estrogen) to treat chronic pelvic pain of endometriosis. Patients with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to those of the estrogen adverse events will be recruited in the Sector of Endometriosis of the Clinical Division of Gynaecological of the Hospital das Clínicas of the Faculty of Medicine of the University of Sao Paulo. The selection process was carried out through the analysis of medical charts and self-completing of structured questionnaires. Satisfied the inclusion criteria, fifty patients were randomly and distributed to receive dynamized estrogen or placebo. The primary clinical outcome is the severity of the chronic pelvic pain. Statistical analysis will be by intention-to-treat and per protocol comparing homeopathic drug with placebo after 24 weeks of intervention.
- Conditions
- Endometriosis, Pelvic Pain
- Being tested
- dynamized estrogen, placebo
- Keywords
- Endometriosis, Pelvic pain, Homeopathy, RCT
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamized estrogenDrug
Also called dynamized 17-beta estradiol
The dosage of the homeopathic medicine or placebo will be of 3 drops, 2 times a day throughout the period of study, and can be reduced in case of finding of homeopathic aggravation of symptoms. 30 ml bottles will be sufficient for the proposed dosage every 8 weeks of treatment (bimensal period).
placeboDrug
Also called alcohol solution
The dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study.
| Study group | Role | What they receive |
|---|---|---|
| dynamized estrogen in alcohol solution | Active comparator | Dynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies. Receives: Drug: dynamized estrogen |
| placebo (alcohol solution) | Placebo comparator | This arm received alcohol solution during the 24-week study duration. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic pelvic pain (measured by visual analog scale (VAS-Pain)
chronic pelvic pain (dysmenorrhoea, dyspareunia, acyclic pelvic pain depth, cyclic intestinal change and cyclic urinary change) measured by visual analog scale (VAS-Pain)
Measured: 24 weeks (6 months)
Secondary outcomes (1)
36-Item Short-Form Health Survey (SF-36)
Measured: 24 weeks (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Zulian Teixeira, University of Sao Paulo General Hospital
- Investigators
- Marcus Z Teixeira, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427386
- Sponsor's protocol ID
- FMUSP
- Status last verified
- Feb 2017
- First submitted
- 22 Apr 2015
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Teixeira MZ. 'New Homeopathic Medicines' database: A project to employ conventional drugs according to the homeopathic method of treatment. European Journal of Integrative Medicine 5(3): 270-278, 2013.
Teixeira MZ, Podgaec S, Baracat EC. Protocol of randomized controlled trial of potentized estrogen in homeopathic treatment of chronic pelvic pain associated with endometriosis. Homeopathy. 2016 Aug;105(3):240-249. doi: 10.1016/j.homp.2016.03.002. Epub 2016 May 13.
PubMed 27473545Teixeira MZ, Podgaec S, Baracat EC. Potentized estrogen in homeopathic treatment of endometriosis-associated pelvic pain: A 24-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:48-55. doi: 10.1016/j.ejogrb.2017.01.052. Epub 2017 Jan 25.
PubMed 28187404Teixeira MZ. Homeopathic use of modern medicines: utilisation of the curative rebound effect. Med Hypotheses. 2003 Feb;60(2):276-83. doi: 10.1016/s0306-9877(02)00386-9.
PubMed 12606247Teixeira MZ. New homeopathic medicines: use of modern drugs according to the principle of similitude. Homeopathy. 2011 Oct;100(4):244-52. doi: 10.1016/j.homp.2011.01.002.
PubMed 21962199
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Randomized Controlled Trial of Dynamized Estrogen in Individualized Homeopathic Treatment of Chronic Pelvic Pain of Endometriosis
- ClinicalTrials.gov ID
- NCT02427386
- Acronym / sponsor ID
- FMUSP
- Conditions
- Endometriosis, Pelvic Pain
- Keywords
- Endometriosis, Pelvic pain, Homeopathy, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Apr 2015 (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.
Endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat. In view of this, many patients seek assistance in complementary and alternative medicine, including homeopathic treatment. The absence of evidence in the literature raises controversy about the effectiveness of homeopathic treatment in endometriosis. The aim of this randomized trial is to evaluate the effectiveness of dynamized estrogen compared to placebo in the treatment of chronic pelvic pain of endometriosis.
Detailed description
This is a randomized, double-blind and placebo controlled trial using individualised homeopathic medicine (dynamized estrogen) to treat chronic pelvic pain of endometriosis. Patients with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to those of the estrogen adverse events will be recruited in the Sector of Endometriosis of the Clinical Division of Gynaecological of the Hospital das Clínicas of the Faculty of Medicine of the University of Sao Paulo. The selection process was carried out through the analysis of medical charts and self-completing of structured questionnaires. Satisfied the inclusion criteria, fifty patients were randomly and distributed to receive dynamized estrogen or placebo. The primary clinical outcome is the severity of the chronic pelvic pain. Statistical analysis will be by intention-to-treat and per protocol comparing homeopathic drug with placebo after 24 weeks of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dynamized estrogen in alcohol solution | Active comparator | Drug: dynamized estrogenDynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies. |
| placebo (alcohol solution) | Placebo comparator | Drug: placeboThis arm received alcohol solution during the 24-week study duration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- aged between 18 and 45;
- diagnosis of endometriosis (endometrial ectopia) confirmed by imaging test (MRI or TVUS) or laparoscopy (biopsy);
- chronic pelvic pain refractory to conventional hormone treatments and with intensity ≥ 5 on the visual analog pain scale (VAS-Pain: 0-10 points);
- symptomatic individualization of patients according to adverse events of estrogen (minimum syndrome of maximum value).
Key exclusion criteria (2 listed)
- absence of clinical and laboratory diagnosis of menopause or
- premature ovarian failure
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 |
|---|---|---|
| dynamized estrogenAlso: dynamized 17-beta estradiolThe dosage of the homeopathic medicine or placebo will be of 3 drops, 2 times a day throughout the period of study, and can be reduced in case of finding of homeopathic aggravation of symptoms. 30 ml bottles will be sufficient for the proposed dosage every 8 weeks of treatment (bimensal period). | Drug | dynamized estrogen in alcohol solution |
| placeboAlso: alcohol solutionThe dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study. | Drug | placebo (alcohol solution) |
Primary outcome
chronic pelvic pain (measured by visual analog scale (VAS-Pain)
Time frame: 24 weeks (6 months)
chronic pelvic pain (dysmenorrhoea, dyspareunia, acyclic pelvic pain depth, cyclic intestinal change and cyclic urinary change) measured by visual analog scale (VAS-Pain)
1 secondary outcome
36-Item Short-Form Health Survey (SF-36)
Time frame: 24 weeks (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 24 Feb 2017.
- BackgroundTeixeira MZ. 'New Homeopathic Medicines' database: A project to employ conventional drugs according to the homeopathic method of treatment. European Journal of Integrative Medicine 5(3): 270-278, 2013.
- Background: PubMed 27473545Teixeira MZ, Podgaec S, Baracat EC. Protocol of randomized controlled trial of potentized estrogen in homeopathic treatment of chronic pelvic pain associated with endometriosis. Homeopathy. 2016 Aug;105(3):240-249. doi: 10.1016/j.homp.2016.03.002. Epub 2016 May 13.
- Background: PubMed 28187404Teixeira MZ, Podgaec S, Baracat EC. Potentized estrogen in homeopathic treatment of endometriosis-associated pelvic pain: A 24-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:48-55. doi: 10.1016/j.ejogrb.2017.01.052. Epub 2017 Jan 25.
- Results publication: PubMed 12606247Teixeira MZ. Homeopathic use of modern medicines: utilisation of the curative rebound effect. Med Hypotheses. 2003 Feb;60(2):276-83. doi: 10.1016/s0306-9877(02)00386-9.
- Results publication: PubMed 21962199Teixeira MZ. New homeopathic medicines: use of modern drugs according to the principle of similitude. Homeopathy. 2011 Oct;100(4):244-52. doi: 10.1016/j.homp.2011.01.002.
- New homeopathic medicines: use of modern drugs according to the principle of similitudeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Marcus Z Teixeira, PhD principal investigator
University of Sao Paulo General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dynamized estrogen in people with Endometriosis and Pelvic Pain, run by University of Sao Paulo General Hospital.
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 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: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
chronic pelvic pain (measured by visual analog scale (VAS-Pain) (time frame: 24 weeks (6 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 NCT02427386, which also lists 5 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 24 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.