Treatment of symptoms related to endometriosis MedDRA version: 14.1 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Estradiol sulfamate
Product Code: PGL2001
Pharmaceutical Form: Tablet
CAS Number: 172377-52-5
Current Sponsor code: PGL2001
Other descriptive name: J995, ZK190628, Estradiol Sulfamate, E
Sponsors
PregLem S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must: 1.Provide written informed consent prior to initiation of any study related procedures. 2.Be a woman of reproductive age between 18 and 45 years inclusive at screening. 3.Have a FSH =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects must not: 1.Be pregnant or currently lactating. 2.Have diseases or suspected diseases which may cause pelvic pain not due to endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis). 3.Have had any surgical treatment for endometriosis within the last 12 months 4.Have documented significant adenomyosis. 5.Have a history of or a current uterus, cervix, ovarian or breast cancer. 6.Have a history of atypical endometrial hyperplasia which has not been diagnosed as reversed to benign endometrium. 7.Have a significant finding on Papanikolaou test (PAP) smear within the past 12 months. 8.Desire to conceive within the course of the study. 9.Have significant adnexal abnormalities other than endometriosis. 10.Have any chronic disease (e.g. hepatic or renal impairment) or conditions that could modify the absorption, distribution, metabolism, or excretion of the drugs under investigation. 11.Suffering from chronic pain and requiring or be likely to require any pain medication (NSAIDs and Non-NSAIDs) during the study 12.Take or have taken any hormonal treatment within the last 6 months 13.Take or have taken at any time therapies for endometriosis other than NSAID’s (e.g. GnRH agonist or antagonist, OC pills continuously (28 day regimen) or danazol). 14.Be likely to require treatment with drugs that are not permitted during the study such as: a.Drugs interacting with CYP3A4 metabolism (inhibition or induction, listed in Appendix C) or carbonic anhydrase inhibition (see section 6.6.2). b.Hormonal contraceptives including progestin releasing devices. c.GnRH-Agonists/ Antagonists d.Danazol e.Tranexamic acid 15.Have abnormal hepatic function at study entry, defined as AST, ALT, GGT, alkaline phosphatase or total bilirubin above twice upper limit of normal. In case of isolated GGT increase, a single retest is allowed 16.Have contraindications to progestins such as: a.thromboembolic disorders, b.arterial and cardiovascular disease, c.diabetes mellitus with vascular involvement, d.liver tumour, e.Dubin-Johnson or Rotor syndrome. 17.Have contraindication or intolerance to NSAIDs. 18.Have any clinically relevant allergy or drug hypersensitivity. 19.Be at risk of haemolysis: a.Subjects having a known sickle cell disease or a known G6PD deficiency. b.Subjects likely to need medication causing haemolysis (e.g. dapsone, sulfasalazine, primaquine, etc.) during the course of the study. 20.Have abnormal baseline findings or any other medical condition(s), which in the opinion of the investigator, may jeopardise the subject’s safety or decrease the chance of obtaining reliable data. 21.Positive serology for HIV, Hepatitis B and C 22.Have a history of, or known current problems with alcohol or drug abuse. 23.Have psychiatric disturbance or be otherwise unlikely to follow the study procedures. 24.Have participated in another clinical trial within the 30 days prior to the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy of PGL2001 with concomitant, continuous NETA administration versus placebo with concomitant, continuous NETA administration to relieve pain symptoms associated with endometriosis by Week 16 (end of PGL2001 treatment);Secondary Objective: •To evaluate the efficacy of PGL2001 with concomitant, continuous NETA administration to relieve pain symptoms associated with endometriosis over 28 weeks after end of treatment with PGL2001 (Week 16 up to Week 44). •To evaluate the safety and tolerability of PGL2001 with concomitant, continuous NETA administration during 16-week PGL2001 treatment period and up to Week44 (28 weeks follow-up period). •To evaluate the efficacy of PGL2001 with concomitant, continuous NETA administration to improve symptoms associated with endometriosis by Week 16 (end of PGL2001 treatment) and up to Week 44 (28 weeks follow-up period). •To evaluate the pharmacokinetics (PK trough levels) of PGL2001 with concomitant, continuous NETA administration during 16 week PGL2001 treatment period and up to Week 44 (28 weeks follow-up period).;Primary end point(s): •Change from baseline to end of double-blind PGL2001/Placebo treatment in non-menstrual pelvic pain as reported using a Visual Analogue Scale (VAS).;Timepoint(s) of evaluation of this end point: After week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Efficacy up to end of the double-blind PGL2001/Placebo treatment period (including PD and PGL2001/PGL2002 Cmin assessments) •Efficacy up to end of follow-up period (including PD and PGL 2001/PGL2002 Cmin assessments) •Safety during the double-blind PGL2001/Placebo treatment and follow-up period.;Timepoint(s) of evaluation of this end point: After week 16 and at the end of study | — |
Countries
Hungary, Poland
Contacts
Public ContactProject Management
Theorem Clinical Research GmbH
Outcome results
None listed