Clinical trial NCT01631981: PGL2001 Proof of Concept Study in Symptomatic Endometriosis
Official title: A Phase II, Multicentre, Randomised, Two-Arm, Parallel Group, Double-Blind, Placebo Controlled Study of the Steroid Sulfatase Inhibitor PGL2001 With Concomitant Administration of NETA (Norethisterone Acetate) for the Treatment of Symptoms Related to Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: PregLem SA
Sponsor class: INDUSTRY
First posted: 2012-06-29
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration for the treatment of pain symptoms suggestive of endometriosis. The target population will be women of reproductive age with symptoms suggestive of endometriosis.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent prior to initiation of any study related procedures.
* Be a woman of reproductive age between 18 and 45 years inclusive.
* Present with clinical signs suggestive of endometriosis.
* Be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit.

Exclusion Criteria:

* Be pregnant or currently lactating.
* Have diseases or suspected diseases which may cause pelvic pain not due to endometriosis.
* Have had any surgical treatment for endometriosis within the last 12 months.
* Have documented significant adenomyosis.
* Have participated in another clinical trial within the 30 days prior to the screening visit.

Primary outcomes:
measure: Non-menstrual pelvic pain.
timeFrame: Daily collection up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Synexus Magyarország Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Szuleszeti es Nogyogyaszati Klinika
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ Szülészeti és Nőgyógyászati Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinkai Központ Szülészeti és Nőgyógyászati Klinika
city: Katowice
country: Poland
facility: Medica Pro Familia Sp. z o.o. S.K.A. - Oddział Katowie
city: Lublin
country: Poland
facility: Specjalistyczny Gabinet Ginekologiczno-Położniczy
city: Poznan
country: Poland
facility: Klinika Endokrynologii I Nieplodnosci Rozrodu, Ginekologiczno Polozniczy Szpital UM
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: Szczecin
country: Poland
facility: VitroLive Sp. Z o.o
city: Warszawa
country: Poland
facility: NZOZ Lecznica Medea
city: Warszawa
country: Poland
facility: Private practice
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA, Klinika Połoznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
city: Łódź
country: Poland
facility: Medeor Plus Szpital Wielospecjalistyczny
city: Łódź
country: Poland
facility: Klinka Ginekologii Operacyjnej, Instytut-Centrum Zdrowia Matki Polki
city: Baia Mare
country: Romania
facility: Euromedica Hospital SA
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
city: Bucharest
country: Romania
facility: Genesys Fertility Center SRL
city: Bucharest
country: Romania
facility: Centrul Medical Euromed SRL
city: Bucharest
country: Romania
facility: Spitalul Clinic "Nicolae Malaxa"
Study officials:
References: