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

Endometriosis Clinical Trial

— END-IMPACT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02669238
• Other study ID #: 2015/CHU/03
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: May 25, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Device:
• Nexplanon®
Subcutaneous implant (Nexplanon®) containing etonogestrel 68 mg

Drug:
• 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)

Locations

Country	Name	City	State
Réunion	CHU de La Réunion	Saint-Denis	Saint Denis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global satisfaction	Global satisfaction evaluated by the SATMED-Q® satisfaction score at 6th month.	6th month of treatment
Secondary	Pain evaluation	Pain evaluation from analogical visual scale	6th and 12th month
Secondary	Daily life impact	Evaluation of daily life impact of endometriosis with Endometriosis Health Profile - 30 (EHP-30)	6th and 12th month
Secondary	Sex life impact	Evaluation of sexual life impact of endometriosis with Female Sexual Function Index (FSFI)	6th and 12th month
Secondary	Evaluation of dysmenorrhea, dyspareunia and pelvic pain	Evaluation of frequency and intensity of dysmenorrhea, dyspareunia and pelvic pain with Biberoglu scale	6th and 12th month
Secondary	Quality of life score	Evaluation of quality of life impact of endometriosis with SF36 scale	6th and 12th month
Secondary	Number of lesions	The number, size, localisation and activity of the lesions is evaluated by Resonance Magnetic Image	Day 1 and 12th month
Secondary	size of lesions	Size of the lesions (mm) is evaluated by Resonance Magnetic Image	Day 1 and 12th month
Secondary	Localisation of lesions	Localisations of the lesions is evaluated by Resonance Magnetic Image	Day 1 and 12th month
Secondary	Incidence of treatment-emergent adverse events (safety and tolerability)	percentage of clinical and biological adverse effects	3rd, 6th, 9th and 12th month