Evaluation of a Subcutaneous Progestogen Implants in the Medical Management of Painful Endometriosis

NCT ID: NCT02669238

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2019-10-10

Brief Summary

Endometriosis is a chronic relapsing disease characterized by the presence and proliferation of endometrial glands and stroma outside the uterus. This is a serious disease, widespread, difficult to live with for the patients, but also difficult to treat for practitioners who take care of these patients. It affects 1.6% of the general population, but its incidence is 10 times higher (up 40%) in patients with infertility. It occurs mainly by complex chronic pelvic pain and a negative influence on fertility.

It is a disease whose complexity can be explained to four levels. Firstly, through its extremely polymorphic character with intraperitoneal superficial forms, ovarian forms and deep sub-peritoneal forms.

Secondly by the plurality of the main symptoms which are individually non-specific and the frequency and / or intensity is not correlated with the severity of the disease. This non-specificity of symptoms partially explains the long lead misdiagnosis, which vary by 5 to 11 years.

Thirdly, by its prevalence which seems very high and largely underestimated. If its precise estimate in the general population is so complicated, it seems very high in many studies of patients supported surgically for gynecological reasons. These very large prevalence figures are observed when some consultations support the hypothesis of a widespread and probably insufficiently evaluated disease.

Lately by its management, insufficiently amended, for which there is currently only a few scientifically supported recommendations.

Chronic pain caused by the disease associated with altered sexuality to a loss of fertility significantly impacts the quality of life of patients.

Detailed Description

Investigators propose a randomized trial comparing two medical alternatives: a continuous monophasic type of estrogen-progestin oral treatment of second generation versus the establishment of an etonogestrel contraceptive implant type.

Are excluded from this study certain absolute surgical indications. Patients, by consenting to participate in the study, choose a medical care, which means not to be operated immediately. They are clearly informed about the various possible treatment alternatives. The benefits and risks of surgery and medical treatment they are explicitly presented. At any time during the study, patients who wish may discuss again a surgical treatment with their physician and stop the study drug if the decision of an intervention is taken.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Implant

Subcutaneous insertion of an progestative implant containing 68mg of etonogestrel

Group Type: EXPERIMENTAL

Nexplanon®

Intervention Type: DEVICE

Subcutaneous implant (Nexplanon®) containing etonogestrel 68 mg

Oral treatment

Continuous oral administration of second generation monophasic oestro-progestative (ethinyl-oestradiol)

Group Type: ACTIVE_COMPARATOR

Minidril®/Leeloo®

Intervention Type: DRUG

continuous per os administration of oestroprogestative treatment. 1 pill a day First line: Minidril® (Levonogestrel 0.15 mg / Ethinylestradiol 0.03 mg) Second line: Leeloo® (Levonogestrel 0.1 mg / Ethinylestradiol 0.02 mg)

Interventions

Nexplanon®

Subcutaneous implant (Nexplanon®) containing etonogestrel 68 mg

Intervention Type: DEVICE

Minidril®/Leeloo®

continuous per os administration of oestroprogestative treatment. 1 pill a day First line: Minidril® (Levonogestrel 0.15 mg / Ethinylestradiol 0.03 mg) Second line: Leeloo® (Levonogestrel 0.1 mg / Ethinylestradiol 0.02 mg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Between 18 and 45 years old
• with a painful symptomatic endometriosis
• with symptoms evolve for more than 6 months
• diagnosis based on clinical and radiological criteria : pain in the examination and/or palpation of endometriosis lesion(s) and lesion(s) objectified by MRI performed and interpreted by a radiologist referent dating less than three months at the time of inclusion
• no history presenting therapeutic surgery for endometriosis
• Accepting medical management
• without hormonal treatment (oestroprogestative, progestative or Luteinizing Hormone-Releasing Hormone (LHRH) analog) since at least 15 days
• No family history of deep venous thromboembolic disorders
• No abnormalities of hemostasis known
• Not pregnant at inclusion visit

Exclusion Criteria

• Patient with a strict indication for surgery (ureteral disease with renal impact, digestive disease with occlusion, infertility with desire for immediate pregnancy, ovarian cyst ≥ 4cm)
• reproductive upper tract infections
• with one or more varicose veins
• with one or more breast abnormalities (ACR 3 or more)
• with contraindication for one of two treatments
• with contraindication for RMI
• taking drug treatment that could alter the concentration of the study treatments

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anca BIRSAN, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

CHU de La Réunion

Saint-Denis, Saint Denis, Reunion

Countries

Reunion

Other Identifiers

2015/CHU/03

Identifier Type: -

Identifier Source: org_study_id