EndometriosisENDOFLEXNCT04150406
Flexofytol® for the Treatment of Endometriosis- Associated Pain
A study testing Flexofytol in people with Endometriosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Endometriosis is a benign disease that affects 6-10% of women of reproductive age. The wide range of symptoms observed in patients with endometriosis is due to implantation of endometrial tissue outside the uterine cavity. This ectopic endometrium is subjected to cyclic changes similar to that of eutopic endometrium. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Flexofytol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteAustria
- Study dates
- 22 Oct 2019to 31 Dec 2021
- Phase
- Interventional
- 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 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women between the ages of 18 and 51 years
- Ability to comprehend the full nature and purpose of the study
- Signed informed consent
- Diagnosed endometriosis (peritoneal, ovarian or deep-infiltrating endometriosis (DIE))
- By laparoscopy or laparotomy with histological verification diagnosed up to 10 years before screening
- By ultrasound or MRI (ovarian or deep-infiltrating endometriosis, as peritoneal lesions can only be evaluated surgically)
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- Moderate to severe pelvic pain (i.e. dysmenorrhea or NMPP of at least 4 on the 1-10 NRS) at least during the past 3 months
- Refusal of hormonal treatments
- The patient must agree to switch from her usual analgesic rescue medication to only the one permitted by the study during screening, treatment and follow-up period
Who cannot join
- The patient is pregnant or breast feeding or is planning a pregnancy within the treatment period
- Known addiction (alcohol, drugs, pills, etc...)
- Liver or kidney problems
- Known problems of the bile system
- Infection (HIV, Hepatitis, TBC, etc..) or systemic autoimmune diseases
- Known or suspected malignant disease
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- Intake of blood-thinning medication (such as heparin or aspirin for example)
- Intake of hormonal contraceptives (oral during the last 4 weeks, injectable: during the last 3 months)
- Patient with a surgical history of hysterectomy, bilateral adnexectomy, endometrial ablation resulting in amenorrhea
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
General Hospital of Vienna, Medical University of Vienna
Vienna, 1090
René Wenzl, Prof. Dr.
About this study
Official title: Flexofytol®, a Curcuma Extract, for the Treatment of Endometriosis- Associated Pain: a Randomized, Double Blind, Placebo-controlled Study
Endometriosis is a benign disease that affects 6-10% of women of reproductive age. The wide range of symptoms observed in patients with endometriosis is due to implantation of endometrial tissue outside the uterine cavity. This ectopic endometrium is subjected to cyclic changes similar to that of eutopic endometrium. Typically, ectopic lesions are found in the pelvis, notably on the ovaries in the form of cysts (endometriomas), as well as the rectouterine and vesicouterine pouch. Lesions have also been described in other parts of the abdomen and in other locations outside the abdominal cavity.
Although endometriosis has also been described in asymptomatic patients, possible symptoms range from mild to severe pain presenting itself as dysmenorrhea, dyspareunia, or dyschezia, or as infertility. Since the clinical picture varies, the treatment of this disease has become quite personalized. Many studies conducted over the past several years have presented different treatment options for the symptoms caused by endometriosis.
Read more
Turmeric, which is won from the rootstalks of Curcuma longa, has more than 300 biologically active elements. One of the three main curcuminoids that are derived from turmeric, is curcumin. Several in-vitro and animal studies have described anti-oxidant, anti-inflammatory and anti-angiogenic effects of curcumin.
The main objective for the treatment of endometriosis patients is symptom relief. Treatment options include analgesic therapies, hormonal therapies, laparoscopic surgery or a combination of these. For patients who refuse hormonal therapies however, conservative treatment options are limited.
Curcuma is a substance that has been in use for centuries, especially in ayurvedic and Traditional Chinese Medicine for the treatment of various symptoms, notably for pain alleviation in inflammatory illnesses. Several recently published studies have shown very promising results of Flexofytol for pain alleviation in patients with osteoarthritis, due to its anti-inflammatory and anti-oxidant properties. Due to these properties of curcuma, we aim to analyse if curcuma capsules, sold by the pharmaceutical company Tilman under the name Flexofytol®, can be used to alleviate symptoms in patients suffering from endometriosis.
- Conditions
- Endometriosis
- Being tested
- Flexofytol, Placebo
- Keywords
- Curcuma, Endometriosis-associated pain
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexofytolDietary supplement
Curcuma extract
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Flexofytol | Active comparator | 2 capsules containing 42mg of curcumin will be administered twice a day for a duration of 4 months. Receives: Dietary Supplement: Flexofytol |
| Placebo | Placebo comparator | 2 capsules of the placebo, identical in appearance to Flexofytol, will be administeres twice a day for a duration of 4 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the average pain score from baseline to 4 months after begin of treatment
Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4 months
Secondary outcomes (6)
Change in number of days with pain ≥ NRS 4 from baseline to 4 months after begin of treatment
Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4 months
Alleviation of dyspareunia using the NRS between 0 and 10, from baseline to 4 months after begin of treatment points)
Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4 months
Alleviation of dysuria using the NRS between 0 and 10 points, from baseline to 4 months after begin of treatment
Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4 months
Alleviation of dyschezia using the NRS between 0 and 10 points from baseline to 4 months after begin of treatment
Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: 4 months
Change in quality of life (using the numerical score of the Endometriosis health profile - EHP 30)
evaluated using a scale of 0 - 100, where 0 indicates the best health status and 100 the worst health status
Measured: 4 months
Change in sexual function (using the numerical score of the female sexual function index - FSFI)
each question answered using a score from 0 to 5, 0 indicating no sexual activity, and, depending on the question, 1 indicating high satisfaction or high frequency, to 5 indicating low satisfaction or low frequency.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start22 Oct 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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 Medical University of ViennaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Perricos, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150406
- Sponsor's protocol ID
- 1712/2019
- Acronym
- ENDOFLEX
- Status last verified
- Oct 2019
- First submitted
- 29 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- 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 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexofytol®, a Curcuma Extract, for the Treatment of Endometriosis- Associated Pain: a Randomized, Double Blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04150406
- Acronym / sponsor ID
- ENDOFLEX / 1712/2019
- Conditions
- Endometriosis
- Keywords
- Curcuma, Endometriosis-associated pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Nov 2019 (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 is a benign disease that affects 6-10% of women of reproductive age. The wide range of symptoms observed in patients with endometriosis is due to implantation of endometrial tissue outside the uterine cavity. This ectopic endometrium is subjected to cyclic changes similar to that of eutopic endometrium. Typically, ectopic lesions are found in the pelvis, notably on the ovaries in the form of cysts (endometriomas), as well as the rectouterine and vesicouterine pouch. Lesions have also been described in other parts of the abdomen and in other locations outside the abdominal cavity.
Although endometriosis has also been described in asymptomatic patients, possible symptoms range from mild to severe pain presenting itself as dysmenorrhea, dyspareunia, or dyschezia, or as infertility. Since the clinical picture varies, the treatment of this disease has become quite personalized. Many studies conducted over the past several years have presented different treatment options for the symptoms caused by endometriosis.
Turmeric, which is won from the rootstalks of Curcuma longa, has more than 300 biologically active elements. One of the three main curcuminoids that are derived from turmeric, is curcumin. Several in-vitro and animal studies have described anti-oxidant, anti-inflammatory and anti-angiogenic effects of curcumin.
The main objective for the treatment of endometriosis patients is symptom relief. Treatment options include analgesic therapies, hormonal therapies, laparoscopic surgery or a combination of these. For patients who refuse hormonal therapies however, conservative treatment options are limited.
Curcuma is a substance that has been in use for centuries, especially in ayurvedic and Traditional Chinese Medicine for the treatment of various symptoms, notably for pain alleviation in inflammatory illnesses. Several recently published studies have shown very promising results of Flexofytol for pain alleviation in patients with osteoarthritis, due to its anti-inflammatory and anti-oxidant properties. Due to these properties of curcuma, we aim to analyse if curcuma capsules, sold by the pharmaceutical company Tilman under the name Flexofytol®, can be used to alleviate symptoms in patients suffering from endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexofytol | Active comparator | Dietary Supplement: Flexofytol2 capsules containing 42mg of curcumin will be administered twice a day for a duration of 4 months. |
| Placebo | Placebo comparator | Other: Placebo2 capsules of the placebo, identical in appearance to Flexofytol, will be administeres twice a day for a duration of 4 months. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Premenopausal women between the ages of 18 and 51 years
- Ability to comprehend the full nature and purpose of the study
- Signed informed consent
- Diagnosed endometriosis (peritoneal, ovarian or deep-infiltrating endometriosis (DIE))
- By laparoscopy or laparotomy with histological verification diagnosed up to 10 years before screening
Key exclusion criteria (9 listed)
- The patient is pregnant or breast feeding or is planning a pregnancy within the treatment period
- Known addiction (alcohol, drugs, pills, etc...)
- Liver or kidney problems
- Known problems of the bile system
- Infection (HIV, Hepatitis, TBC, etc..) or systemic autoimmune diseases
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 |
|---|---|---|
| FlexofytolCurcuma extract | Dietary supplement | Flexofytol |
| Placeboplacebo | Other | Placebo |
Primary outcome
Change of the average pain score from baseline to 4 months after begin of treatment
Time frame: 4 months
Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
6 secondary outcomes
Change in number of days with pain ≥ NRS 4 from baseline to 4 months after begin of treatment
Time frame: 4 months
Alleviation of dyspareunia using the NRS between 0 and 10, from baseline to 4 months after begin of treatment points)
Time frame: 4 months
Alleviation of dysuria using the NRS between 0 and 10 points, from baseline to 4 months after begin of treatment
Time frame: 4 months
Alleviation of dyschezia using the NRS between 0 and 10 points from baseline to 4 months after begin of treatment
Time frame: 4 months
Change in quality of life (using the numerical score of the Endometriosis health profile - EHP 30)
Time frame: 4 months
Change in sexual function (using the numerical score of the female sexual function index - FSFI)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexofytol in people with Endometriosis, run by Medical University of Vienna at 1 site in Austria.
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 9 inclusion and 9 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 4 Nov 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 Austria. 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.
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 Alexandra Perricos, Dr. (+4369918068650, alexandra.perricos@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the average pain score from baseline to 4 months after begin of treatment (time frame: 4 months). 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 4 Nov 2019.