Flexofytol® for the Treatment of Endometriosis- Associated Pain (ENDOFLEX)
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|ClinicalTrials.gov Identifier: NCT04150406|
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Dietary Supplement: Flexofytol Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Flexofytol®, a Curcuma Extract, for the Treatment of Endometriosis- Associated Pain: a Randomized, Double Blind, Placebo-controlled Study|
|Actual Study Start Date :||October 22, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: Flexofytol
2 capsules containing 42mg of curcumin will be administered twice a day for a duration of 4 months.
Dietary Supplement: Flexofytol
Placebo Comparator: Placebo
2 capsules of the placebo, identical in appearance to Flexofytol, will be administeres twice a day for a duration of 4 months.
- 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).
- Change in number of days with pain ≥ NRS 4 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).
- Alleviation of dyspareunia using the NRS between 0 and 10, from baseline to 4 months after begin of treatment points) [ Time Frame: 4 months ]Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
- 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 ]evaluated using a scale of 0 - 100, where 0 indicates the best health status and 100 the worst health status
- Change in sexual function (using the numerical score of the female sexual function index - FSFI) [ Time Frame: 4 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150406
|Contact: Alexandra Perricos, Dr.||+email@example.com|
|Contact: René Wenzl, Prof. Dr.||+firstname.lastname@example.org|
|General Hospital of Vienna, Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: René Wenzl, Prof. Dr.|