EndometriosisPhase 2/3END-IMPACTNCT02669238
Evaluation of a Subcutaneous Progestogen Implants in the Medical Management of Painful Endometriosis
A Phase 2/3 study testing Nexplanon® and Minidril®/Leeloo® in people with Endometriosis, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Nexplanon® and Minidril®/Leeloo®
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteReunion
- Study dates
- 25 May 2018to 10 Oct 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Nexplanon®, Minidril®/Leeloo®
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexplanon®Device
Subcutaneous implant (Nexplanon®) containing etonogestrel 68 mg
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)
| Study group | Role | What they receive |
|---|---|---|
| Implant | Experimental | Subcutaneous insertion of an progestative implant containing 68mg of etonogestrel Receives: Device: Nexplanon® |
| Oral treatment | Active comparator | Continuous oral administration of second generation monophasic oestro-progestative (ethinyl-oestradiol) Receives: Drug: Minidril®/Leeloo® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global satisfaction
Global satisfaction evaluated by the SATMED-Q® satisfaction score at 6th month.
Measured: 6th month of treatment
Secondary outcomes (9)
Pain evaluation
Pain evaluation from analogical visual scale
Measured: 6th and 12th month
Daily life impact
Evaluation of daily life impact of endometriosis with Endometriosis Health Profile - 30 (EHP-30)
Measured: 6th and 12th month
Sex life impact
Evaluation of sexual life impact of endometriosis with Female Sexual Function Index (FSFI)
Measured: 6th and 12th month
Evaluation of dysmenorrhea, dyspareunia and pelvic pain
Evaluation of frequency and intensity of dysmenorrhea, dyspareunia and pelvic pain with Biberoglu scale
Measured: 6th and 12th month
Quality of life score
Evaluation of quality of life impact of endometriosis with SF36 scale
Measured: 6th and 12th month
Number of lesions
The number, size, localisation and activity of the lesions is evaluated by Resonance Magnetic Image
Measured: Day 1 and 12th month
size of lesions
Size of the lesions (mm) is evaluated by Resonance Magnetic Image
Measured: Day 1 and 12th month
Localisation of lesions
Localisations of the lesions is evaluated by Resonance Magnetic Image
Measured: Day 1 and 12th month
Incidence of treatment-emergent adverse events (safety and tolerability)
percentage of clinical and biological adverse effects
Measured: 3rd, 6th, 9th and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start25 May 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anca BIRSAN, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669238
- Sponsor's protocol ID
- 2015/CHU/03
- Acronym
- END-IMPACT
- Status last verified
- Mar 2020
- First submitted
- 22 Oct 2015
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Subcutaneous Progestogen Implants in the Medical Management of Painful Endometriosis
- ClinicalTrials.gov ID
- NCT02669238
- Acronym / sponsor ID
- END-IMPACT / 2015/CHU/03
- Conditions
- Endometriosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant | Experimental | Device: Nexplanon®Subcutaneous insertion of an progestative implant containing 68mg of etonogestrel |
| Oral treatment | Active comparator | Drug: Minidril®/Leeloo®Continuous oral administration of second generation monophasic oestro-progestative (ethinyl-oestradiol) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexplanon®Subcutaneous implant (Nexplanon®) containing etonogestrel 68 mg | Device | Implant |
| 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) | Drug | Oral treatment |
Primary outcome
Global satisfaction
Time frame: 6th month of treatment
Global satisfaction evaluated by the SATMED-Q® satisfaction score at 6th month.
9 secondary outcomes
Pain evaluation
Time frame: 6th and 12th month
Daily life impact
Time frame: 6th and 12th month
Sex life impact
Time frame: 6th and 12th month
Evaluation of dysmenorrhea, dyspareunia and pelvic pain
Time frame: 6th and 12th month
Quality of life score
Time frame: 6th and 12th month
Number of lesions
Time frame: Day 1 and 12th month
size of lesions
Time frame: Day 1 and 12th month
Localisation of lesions
Time frame: Day 1 and 12th month
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: 3rd, 6th, 9th and 12th month
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anca BIRSAN, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nexplanon® and Minidril®/Leeloo® in people with Endometriosis, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global satisfaction (time frame: 6th month of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.