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

NCT02669238 | Terminated Phase 2 DMC

• 1 other identifier: 2015/CHU/03
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Global satisfaction

  Global satisfaction evaluated by the SATMED-Q® satisfaction score at 6th month.

  6th month of treatment

Secondary Outcomes (9)

• Pain evaluation

  6th and 12th month

• Daily life impact

  6th and 12th month

• Sex life impact

  6th and 12th month

• Evaluation of dysmenorrhea, dyspareunia and pelvic pain

  6th and 12th month

• Quality of life score

  6th and 12th month

Study Arms (2)

Implant

EXPERIMENTAL

Subcutaneous insertion of an progestative implant containing 68mg of etonogestrel

Device: Nexplanon®

Oral treatment

ACTIVE COMPARATOR

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

Drug: Minidril®/Leeloo®

Interventions

Nexplanon® DEVICE

Subcutaneous implant (Nexplanon®) containing etonogestrel 68 mg

Implant

Minidril®/Leeloo® 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)

Oral treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 45 years old
• with a painful symptomatic endometriosis
• with symptoms evolve for more than 6 months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

CHU de La Réunion

Saint-Denis, Saint Denis, 97400, Reunion

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Anca BIRSAN, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: February 1, 2016
• Study Start: May 25, 2018
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)