Study to determine the efficacy and safety of PGL2001 for the symptoms related to endometriosis, when taken with norethisterone acetate

• Conditions: Treatment of symptoms related to endometriosis; MedDRA version: 14.1Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2011-005167-24-HU
• Lead Sponsor: PregLem S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-27
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 132

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 < 30 mlU/ml (taken at Day 2-4 of menstrual cycle).
4.Have a BMI of 18 – 30 kg/m2 (inclusive).
5.Have a score of = 40 on the pain index of the EHP-30
6.Have a history of regular menstrual cycles (22-36 days) while not being on oral contraceptive pills (at least 6 months since stopping of OC).
7.Be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit.
8.Present with clinical signs suggestive of endometriosis (e.g. painful gynaecological exam, palpable endometriotic lesions, radiologic or ultrasound suspicion of endometriosis).
9.Be able and willing to comply with the requirements of the protocol.
10.Must use a barrier method or abstinence if sexually active with a male partner for the first 7 days of treatment if NETA administration was not done on day 1 of the menstrual cycle.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 132
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified