Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 13 for:    "Endometriosis" | "Ethinyl Estradiol"

Evaluation of a Subcutaneous Progestogen Implants in the Medical Management of Painful Endometriosis (END-IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02669238
Recruitment Status : Not yet recruiting
First Posted : February 1, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

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.


Condition or disease Intervention/treatment Phase
Endometriosis Device: Nexplanon® Drug: Minidril®/Leeloo® Phase 2 Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Subcutaneous Progestogen Implants in the Medical Management of Painful Endometriosis
Study Start Date : June 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Implant
Subcutaneous insertion of an progestative implant containing 68mg of etonogestrel
Device: Nexplanon®
Subcutaneous implant (Nexplanon®) containing etonogestrel 68 mg

Active Comparator: Oral treatment
Continuous oral administration of second generation monophasic oestro-progestative (ethinyl-oestradiol)
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)




Primary Outcome Measures :
  1. Global satisfaction [ Time Frame: 6th month of treatment ]
    Global satisfaction evaluated by the SATMED-Q® satisfaction score at 6th month.


Secondary Outcome Measures :
  1. Pain evaluation [ Time Frame: 6th and 12th month ]
    Pain evaluation from analogical visual scale

  2. Daily life impact [ Time Frame: 6th and 12th month ]
    Evaluation of daily life impact of endometriosis with Endometriosis Health Profile - 30 (EHP-30)

  3. Sex life impact [ Time Frame: 6th and 12th month ]
    Evaluation of sexual life impact of endometriosis with Female Sexual Function Index (FSFI)

  4. Evaluation of dysmenorrhea, dyspareunia and pelvic pain [ Time Frame: 6th and 12th month ]
    Evaluation of frequency and intensity of dysmenorrhea, dyspareunia and pelvic pain with Biberoglu scale

  5. Quality of life [ Time Frame: 6th and 12th month ]
    Evaluation of quality of life impact of endometriosis with SF36 scale

  6. Number of lesions [ Time Frame: Day 1 and 12th month ]
    The number, size, localisation and activity of the lesions is evaluated by Resonance Magnetic Image

  7. size of lesions [ Time Frame: Day 1 and 12th month ]
    Size of the lesions (mm) is evaluated by Resonance Magnetic Image

  8. Localisation of lesions [ Time Frame: Day 1 and 12th month ]
    Localisations of the lesions is evaluated by Resonance Magnetic Image

  9. Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: 3rd, 6th, 9th and 12th month ]
    percentage of clinical and biological adverse effects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669238


Contacts
Layout table for location contacts
Contact: Samir MEDJANE +262 (0)262906286 samir.medjane@chu-reunion.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Investigators
Layout table for investigator information
Principal Investigator: Anca BIRSAN, MD

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT02669238     History of Changes
Other Study ID Numbers: 2015/CHU/03
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Endometriosis
Genital Diseases, Female
Etonogestrel
Progestins
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists