A clinical study in women suffering from endometriosis to test the drug LPRI-CF113 (drospirenone) during 6 months of treatment

Phase 1

• Conditions: Endometriosis; MedDRA version: 20.0Level: 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: EUCTR2021-001424-17-CZ
• Lead Sponsor: Chemo Research S. L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-03
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 236

Inclusion Criteria

1. Postmenarcheal and premenopausal female subjects = 18 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 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? 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 226
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (< 3 months prior to Visit 1a) surgery, incl. low invasive
laparoscopy, the investigator should confirm that the subject has fully
recovered.
5.Any other pathology associated with chronic pain (e.g. fibromyalgia, chronic back pain, chronic headaches, etc.).
6.Laboratory values, heart rate and/or electrocardiogram assessment at screening which are considered clinically significant and which in the opinion of the investigator would be detrimental for participation in the trial.
7.Known contraindication to the use of LPRI-CF113:
a)Active venous thromboembolic disorder.
b)Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
c)Severe renal insufficiency or acute renal failure.
d)Known or suspected sex-steroid sensitive malignancies.
e)Undiagnosed vaginal bleeding.
f)Hypersensitivity to the active substance or to any of the excipients.
8.Currently ongoing conditions or previous history of:
a)Cerebral-vascular or coronary-artery disease which includes myocardial infarction, angina pectoris.
b)Valvular heart disease with thrombogenic complications.
c)Headaches with focal neurological symptoms.
d)Known or suspected carcinoma of the breast.
e)Arterial and cardiovascular disease, past or present (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease).
f)Diabetes mellitus with vascular involvement.
g)Adrenal insufficiency.
h)History of cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use.
i)Hyperkalaemia.
j)Hysterectomy.
9.Major surgery with more than 7 days of immobilisation within the 2 weeks prior to screening.
10.Uncontrolled concomitant diseases (i.e. not on a stable treatment dose for at least 2 months before screening).
11.Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to screening).
12.Known or suspected human immunodeficiency virus (HIV) and/or hepatitis infection at screening.
13.Received a dose of depot medroxyprogesterone acetate (DMPA or Depo-Provera®) within the last 10 months prior to screening, or received any combined injectable contraceptive (e.g. Cyclofem®) within the last 6 months prior to screening, or no spontaneous menses since last injection.
14.Long-term treatment (> 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
m)St. John’s wort (hypericum perforatum)

Study & Design

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