Endometriosis MedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Drospirenone
Product Code: LPRI-CF113
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DROSPIRENONE
CAS Number: 67392-87-4
Current Sponsor code: LPRI-CF113
Other descriptive
Sponsors
Chemo Research S. L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Postmenarcheal and premenopausal female subjects = 15 and = 45 years of age at screening, not seeking pregnancy. 2. Endometriosis was diagnosed by laparoscopy at least 6 weeks before Visit 1a and either a. histological confirmation was documented, OR b. in cases where histological confirmation is not available, the complete laparoscopy report with a visual confirmation of the diagnosis is available to the investigator. 3. EAPP of = 3 points on an NRS during the last 3 months before screening. 4. Be able and willing to provide written informed consent or assent before any trial-related procedure will be performed. 5. In females not using a hormonal contraceptive at screening: regular menstrual cycles (i.e. cycle length between 21 and 35 days) during the last 3 months before screening. 6. Willing to agree to one wash-out cycle of hormonal therapies, if applicable. 7. Willing to use one agreed NSAID or paracetamol as rescue medication throughout the trial. No switching or start of an additional pain killer should be planned after Visit 1a until the end of the trial. 8. Systolic blood pressure = 140 mmHg and diastolic blood pressure = 90 mmHg at screening, in a sitting position after 5 minutes of rest. 9. Willing to use IP for six 28-day cycles. 10. Willing to use reliable non-hormonal contraceptive methods (condoms, female or male sterilisation or sexual abstinence [if in line with the preferred and usual lifestyle of the subject]) during the course of the trial. 11. Be in good physical (apart from endometriosis) and mental health according to medical history and general physical examination performed at screening. 12. Willing to adhere to the prohibitions and restrictions specified in the protocol. 13. Agree not to participate in any other clinical trials during the course of this trial. Inclusion criteria at Visit 1b: 14. Have completed the e-diary in accordance with the e-diary instructions and with no more than 1 missed entry per each week during the last 28 days before Visit 1b. 15. Have regular menstrual cycles (i.e. cycle length between 21 and 35 days) during the screening period. 16. A mean EAPP score of = 3 points on an NRS within the last 28 days before Visit 1b as assessed by e-diary entries. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 226 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Ongoing pregnancy, wish for pregnancy, and breastfeeding subjects. 2. Subject is known to or suspected of not being able to comply with the trial protocol, the use of IP or trial e-diary. 3. Abnormal finding on pelvic, breast or ultrasound examination other than those related to endometriosis that in the investigator’s opinion contraindicates participation in the trial. 4. Pelvic pain not caused by endometriosis (e.g. interstitial cystitis, presumptive adenomyosis, fibroids, post-surgery pain, etc.). In case of a recent ( 7 consecutive days within a month prior to Visit 1b) of any medication that might interfere with the efficacy of hormonal contraceptives, e.g.: a) Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone, lamotrigine) b) Potent inhibitors of CYP3A4 (fluconazole, ketoconazole, itraconazole or voriconazole). c) Barbiturates d) Antibiotics (such as rifampicin) e) HIV medication (such as ritonavir, nelfinavir, neviparine and efavirenz) f) Hepatitis C virus (HCV) medication (e.g. boceprevir, telaprevir) g) Macrolides (clarithromycin and erythromycin) h) Bosentan i) Griseofulvin j) Verapamil k) Diltiazem l) Cyclosporin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of LPRI-CF113 in the management of Endometriosis Associated Pelvic Pain (EAPP) as assessed on a numeric rating scale (NRS).;Secondary Objective: To assess the efficacy of LPRI-CF113 versus placebo in terms of response to treatment. To assess the safety and tolerability of LPRI-CF113 in comparison to placebo.;Primary end point(s): Changes from baseline in EAPP by the assessment of subject reported pain score on an NRS after 3 medication cycles. Intercurrent events (ICEs) and strategies • Change in rescue medication during 3 medication cycles compared to baseline. • Treatment non-compliance ( 120%). • Discontinuation of treatment (due to lack of efficacy, adverse events [AEs] or safety concerns). ;Timepoint(s) of evaluation of this end point: Number of days corresponding to subjects average menstruation cycle duration, prior to and including Day 28 of medication cycle 3 (or last intake of IP in case of early discontinuation). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in dysmenorrhoea (assessed via NRS pain score). 2. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in NMPP (assessed via NRS pain score). 3. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in rescue medication intake. 4. Changes after 1 and 6 medication cycle(s) compared to baseline in EAPP (assessed via an NRS pain score). 5. Changes after 1, 3 and 6 medication cycle(s) compared to baseline in dyspareunia. 6. Number and percentage of subjects with amenorrhoea. 7. Vaginal bleeding pattern 8. The number and percentage of responders at 3 months (responder will be defined by a 50% EAPP reduction measured through an NRS). 9. Withdrawals due to lack of efficacy (pain relief). 10. Changes after 3 and 6 medication cycles compared to baseline in quality of life (30-item Endometriosis Health Profile Questionnaire [EHP-30]). 11. Patient’s Global Impression of Change (PGIC). 12. Adverse events. 13. Mean absolute and relative changes in laboratory values. 14. Vital signs.;Timepoint(s) of evaluation of this end point: 1, 3 and 6 medication cycles, respectively | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Lithuania, Poland, Slovakia, Spain, Ukraine
Contacts
Public ContactChief Scientific Officer
Chemo Research S.L.
Outcome results
None listed