A pilot study to assess the efficacy and safety of OBE2109 in subjects with rectovaginal endometriosis.
- Conditions
- Rectovaginal endometriosisTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2017-004043-21-FR
- Lead Sponsor
- ObsEva SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 9
1. The subject must provide written informed consent prior to initiation of any study related procedures.
2. The subject must be a pre-menopausal woman aged between 18 and 48 years inclusive at screening.
3. The subject must have history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting or staining.
4. The subject has Follicle-Stimulating Hormone (FSH) level = 20 IU/L at screening.
5. The subject has endometriosis with presence of a rectovaginal node (type II or III) of at least 2 cm at vaginal examination confirmed on MRI, and:
· Moderate to severe scoring on the mB&B scale for two out of the three subject assessed symptoms
(dysmenorrhea, non-menstrual pelvic pain and dyspareunia), and
· Pain during vaginal examination.
6. The subject has a Body Mass Index (BMI) =18 and =35 kg/m².
7. If of childbearing potential, the subject agrees to use one of the following birth control methods during the entire length of the treatment period of the study:
a. Sexual abstinence from heterosexual intercourse if routinely and consistently practised
b. Partner with vasectomy performed at least 6 months prior to the screening visit and with confirmed azoospermia
c. Double non-hormonal barrier contraception such as condom or diaphragm each combined with
spermicide.
8. If of non-childbearing potential, the subject must have had tubal ligation sterilisation at least two months before the screening visit.
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 9
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. The subject has an abnormal endometrial biopsy within 6 months prior to starting study treatment (atypical hyperplasia, endometritis, polyps or carcinoma).
2. The subject has endometrioma with a diameter >3cm.
3. The subject has a previous bowel (rectal or sigmoid) resection.
4. The subject has had surgery for deep endometriosis in the 6 months preceding the screening visit.
5. The subject has had breast examination findings requiring intervention within the 6 months preceding the screening visit.
6. The subject has or has had an active pelvic infection within 1 month preceding the screening visit.
7. The subject is using an intrauterine device (IUD) or has used an IUD within the 3 months preceding the screening visit.
8. The subject is likely to require treatment during the study OR received treatment within a specified period prior to the screening visit with any of the medications listed below:
• Gonadotropin releasing hormone (GnRH) antagonists 3 months
• GnRH agonist injections/3-month depot injections 3 months/6 months
• Oral contraceptives and other sex hormones 1 month
• Depot contraceptives 6 months
• Selective Progesterone Receptor Modulators (SPRMs)
Selective Estrogen Receptor Modulators (SERMs) 3 months
• Systemic glucocorticoid treatments for acute diseases (not depot) 1 month
9. The subject is using or anticipates to use any of the following drugs: anticoagulants, aminocaproic acid, or any other medications that affect menstrual bleeding such as tranexamic acid.
10. The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
11. The subject has history of known failed treatment with GnRH agonists or GnRH antagonists.
12. The subject has history of or current systemic glucocorticoid therapy for treatment of chronic diseases (e.g. Systemic Lupus Erythematosus (SLE), rheumatic arthritis).
13. The subject has history of, or known osteoporosis or other metabolic bone disease.
14. The subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT) or total bilirubin = 2 times the upper limit of normal.
15. The subject has known positive HIV or viral hepatitis serology.
16. The subject has any known condition, including findings in the medical history or in the screening
assessments which, in the opinion of the investigator, constitutes a risk or a contraindication to the
participation of the subject in the trial or that could interfere with the trial objectives, conduct or evaluation.
17. The subject has history of (within twelve months prior to the screening visit), or known current problems with alcohol or drug abuse (including painkiller abuse).
18. The subject has any condition rendering her unable to understand the nature, scope and possible
consequences of the study, and/or evidence of an uncooperative attitude.
19. The subject has been administered any experimental drug in the 12 weeks before start of study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method