EndometriosisPhase 3NCT02437175
Efficacy of Trace Elements in the Treatment of Endometriosis: a Pilot Study
A Phase 3 study testing ENDO 1/ENDO 2 in people with Endometriosis, run by Laboratoires Pronutri at 1 site in Belgium.
Trial summary
The primary objective of this pilot study is to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain in endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- ENDO 1/ENDO 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteBelgium
- Study dates
- 28 May 2015to 31 Dec 2016
- Phase
- Phase 3
- 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
- Written informed consent
- Woman suffering from an AFSr 2 to 4 endometriosis (combined or not to an adenomyosis), confirmed by laparoscopy, laparotomy or MRI as well as by a biopsy (done within 3 years before inclusion in the study), treated or not with sexual hormones, contraceptive or not (stable treatment for minimum 2 months) or any other treatment
- Time period of at least 6 months after surgical treatment
- Age between 18 and 45 years
- Non-menopausal woman
- Baseline pain (Day -45 to -30) of at least 40 mm on a visual analog scale
- No reduction of more than 20% of pain on the visual analog scale after the run-in placebo period.
Who cannot join
- AFSr 1 endometriosis
- Adenomyosis without endometriosis
- Pregnancy
- Existence of another pathology that could interfere with endometriosis and/or with adenomyosis, and the study follow-up
- Psychological or psychiatric conditions
- Patient who, according to the investigator, will not be able to comply to the prerequisites of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Food Supplements Containing Trace Elements in the Treatment of Endometriosis, Combined or Not to an Adenomyosis: a Pilot Study
The primary objective of this pilot study is to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain in endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months.
Read the detailed description
The objectives of this pilot study are to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain, on the quality of life, on the use of rescue medication (ibuprofen) in patients with an endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months. The safety of trace elements versus placebo will also be assessed.
This will be a prospective, interventional, randomized, placebo-controlled, two parallel-group, double-blind study.
Trace elements or placebo are administered in the absence of any other treatment or as add-on treatments to common therapies such as sexual hormones, anti-inflammatory drugs or surgery.
A run-in placebo period of 30 days will allow eliminating the patients who are responding to strongly to a placebo.
The treatment will last for 4 months. The total duration of the study will be 5 months for each patient. Four medical visits (Days -45 to -30, 0, 60 and 120) and two phone contacts (Days 30 and 90) will be scheduled.
A urine pregnancy test will be undertaken at each visit. The quality of life scale (EHP-30) will be filled in on Days 0, 60 and 120. During the whole study period, patients will be asked to fill in a diary, in which they will score their pain on a visual analog scale, their blood loss and their consumption of rescue medication (ibuprofen).
Phone contacts will be used to reinforce the compliance and to collect potential adverse events.
Non-serious and serious adverse events will be collected between Days 0 and 120.
All concomitant medications will be recorded, including the rescue medication between Day -45 and Day 120.
A paper case report form will be used.
A total of 60 patients (30 receiving trace elements and 30 receiving placebo) will be randomized to achieve a total of 50 patients.
- Conditions
- Endometriosis
- Being tested
- ENDO 1/ENDO 2, Placebo
- Keywords
- pelvic pain, quality of life, adenomyosis
- Medical subject headings
- Endometriosis, Pelvic Pain, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDO 1/ENDO 2Dietary supplement
NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days.
PlaceboDietary supplement
Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days. Receives: Dietary Supplement: Placebo |
| Trace elements | Experimental | NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days. Receives: Dietary Supplement: ENDO 1/ENDO 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (visual analog scale)
Pain scored daily by the patient using a visual analog scale
Measured: Day 0 to Day 120
Secondary outcomes (3)
EHP-30 (validated 30-items questionnaire)
Quality of life determined using a validated 30-items questionnaire (EHP-30)
Measured: Day 0 to Day 120
Rescue medication consumption (Number of ibuprofen tablets consumed)
Measured: Day 0 to Day 120
Safety (Non-serious and serious adverse events (related or not)
Non-serious and serious adverse events (related or not)
Measured: Day 0 to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study start28 May 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Pronutri
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Expert Clinical Services Organization (ECSOR)
- Responsible party
- Sponsor
- Investigators
- Didier Oberweis, MD, Principal investigator, CHU Vésale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437175
- Sponsor's protocol ID
- Pronutri-IIIa-001
- Status last verified
- Mar 2022
- First submitted
- 5 May 2015
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Food Supplements Containing Trace Elements in the Treatment of Endometriosis, Combined or Not to an Adenomyosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT02437175
- Acronym / sponsor ID
- Pronutri-IIIa-001
- Conditions
- Endometriosis
- Keywords
- pelvic pain, quality of life, adenomyosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Laboratoires PronutriIndustry (pharma, biotech, devices)
- Collaborators
- Expert Clinical Services Organization (ECSOR)
- Study start
- 28 May 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 7 May 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.
The primary objective of this pilot study is to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain in endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months.
Detailed description
The objectives of this pilot study are to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain, on the quality of life, on the use of rescue medication (ibuprofen) in patients with an endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months. The safety of trace elements versus placebo will also be assessed.
This will be a prospective, interventional, randomized, placebo-controlled, two parallel-group, double-blind study.
Trace elements or placebo are administered in the absence of any other treatment or as add-on treatments to common therapies such as sexual hormones, anti-inflammatory drugs or surgery.
A run-in placebo period of 30 days will allow eliminating the patients who are responding to strongly to a placebo.
The treatment will last for 4 months. The total duration of the study will be 5 months for each patient. Four medical visits (Days -45 to -30, 0, 60 and 120) and two phone contacts (Days 30 and 90) will be scheduled.
A urine pregnancy test will be undertaken at each visit. The quality of life scale (EHP-30) will be filled in on Days 0, 60 and 120. During the whole study period, patients will be asked to fill in a diary, in which they will score their pain on a visual analog scale, their blood loss and their consumption of rescue medication (ibuprofen).
Phone contacts will be used to reinforce the compliance and to collect potential adverse events.
Non-serious and serious adverse events will be collected between Days 0 and 120.
All concomitant medications will be recorded, including the rescue medication between Day -45 and Day 120.
A paper case report form will be used.
A total of 60 patients (30 receiving trace elements and 30 receiving placebo) will be randomized to achieve a total of 50 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days. |
| Trace elements | Experimental | Dietary Supplement: ENDO 1/ENDO 2NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent
- Woman suffering from an AFSr 2 to 4 endometriosis (combined or not to an adenomyosis), confirmed by laparoscopy, laparotomy or MRI as well as by a biopsy (done within 3 years before inclusion in the study), treated or not with sexual hormones, contraceptive or not (stable treatment for minimum 2 months) or any other treatment
- Time period of at least 6 months after surgical treatment
- Age between 18 and 45 years
- Non-menopausal woman
Key exclusion criteria (6 listed)
- AFSr 1 endometriosis
- Adenomyosis without endometriosis
- Pregnancy
- Existence of another pathology that could interfere with endometriosis and/or with adenomyosis, and the study follow-up
- Psychological or psychiatric conditions
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 |
|---|---|---|
| ENDO 1/ENDO 2NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days. | Dietary supplement | Trace elements |
| PlaceboPlacebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days. | Dietary supplement | Placebo |
Primary outcome
Pain (visual analog scale)
Time frame: Day 0 to Day 120
Pain scored daily by the patient using a visual analog scale
3 secondary outcomes
EHP-30 (validated 30-items questionnaire)
Time frame: Day 0 to Day 120
Rescue medication consumption (Number of ibuprofen tablets consumed)
Time frame: Day 0 to Day 120
Safety (Non-serious and serious adverse events (related or not)
Time frame: Day 0 to Day 120
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 22 Mar 2022.
- A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodologyLink provided by the sponsor.
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.
Didier Oberweis, MD principal investigator
CHU Vésale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ENDO 1/ENDO 2 in people with Endometriosis, run by Laboratoires Pronutri at 1 site in Belgium.
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 7 inclusion and 6 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 22 Mar 2022. 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 Belgium. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain (visual analog scale) (time frame: Day 0 to Day 120). 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 22 Mar 2022.