Flexofytol® for the Treatment of Endometriosis- Associated Pain
Nøkkelord
Abstrakt
Datoer
Sist bekreftet: | 09/30/2019 |
Først sendt: | 10/28/2019 |
Anslått påmelding sendt: | 10/30/2019 |
Først lagt ut: | 11/03/2019 |
Siste oppdatering sendt: | 10/30/2019 |
Siste oppdatering lagt ut: | 11/03/2019 |
Faktisk studiestartdato: | 10/21/2019 |
Anslått primær ferdigstillelsesdato: | 06/29/2021 |
Anslått sluttdato for studien: | 12/30/2021 |
Tilstand eller sykdom
Intervensjon / behandling
Dietary Supplement: Flexofytol
Other: Placebo
Fase
Armgrupper
Væpne | Intervensjon / behandling |
---|---|
Active Comparator: Flexofytol 2 capsules containing 42mg of curcumin will be administered twice a day for a duration of 4 months. | Dietary Supplement: Flexofytol Curcuma extract |
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. | Other: Placebo placebo |
Kvalifikasjonskriterier
Alder Kvalifisert for studier | 18 Years Til 18 Years |
Kjønn som kan studeres | Female |
Godtar sunne frivillige | Ja |
Kriterier | Inclusion Criteria: - 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) - 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 Exclusion Criteria: - 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 - 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 |
Utfall
Primære utfallstiltak
1. Change of the average pain score from baseline to 4 months after begin of treatment [4 months]
Sekundære utfallstiltak
1. Change in number of days with pain ≥ NRS 4 from baseline to 4 months after begin of treatment [4 months]
2. Alleviation of dyspareunia using the NRS between 0 and 10, from baseline to 4 months after begin of treatment points) [4 months]
3. Alleviation of dysuria using the NRS between 0 and 10 points, from baseline to 4 months after begin of treatment [4 months]
4. Alleviation of dyschezia using the NRS between 0 and 10 points from baseline to 4 months after begin of treatment [4 months]
5. Change in quality of life (using the numerical score of the Endometriosis health profile - EHP 30) [4 months]
6. Change in sexual function (using the numerical score of the female sexual function index - FSFI) [4 months]