EndometriosisPhase 2NCT04948489
IUD and Norethindrone Acetate for Treatment of Endometriosis
A Phase 2 study testing norethindrone acetate (NETA) in people with Endometriosis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Endometriosis is the most common reproductive disease afflicting young women, often leading to debilitating chronic pelvic pain and impaired quality of life. Safe, effective, and convenient long-term treatments are lacking for adolescents and young adults. Read more about this study
- Who is it for?
- Ages 13 to 24 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- norethindrone acetate (NETA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Sep 2029
- Phase
- Phase 2
- 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 13 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female with surgically confirmed endometriosis
- Clinical decision to begin use of the LNG-IUD
- Age 13 to 24 years
- Current pelvic pain (score ≥ 3 on Visual Analog Scale) that has been present for at least 2 months prior to enrollment
- Willingness to comply with visit schedule and study protocol
Who cannot join
- Pre-menarche or post-menopause
- Previous gonadotropin-releasing agonist use
- Contraindications to an IUD (e.g., cavity-distorting uterine anomaly, acute pelvic inflammatory disease, <3 months from postpartum endometritis or septic abortion, local neoplasm, uterine bleeding of unknown etiology, breast cancer, untreated cervicitis or vaginitis or other lower genital tract infections)
- Active or historical venous thromboembolism, active or recent arterial thromboembolic disease
- Impaired liver function or liver disease
- Systemic lupus erythematosus
Show all 11Show fewer
- Uncontrolled diabetes or uncontrolled hypertension (BPs >140s/90s)
- Hypersensitivity to any component of the NETA or LNG-IUS
- Concurrent use of moderate or strong CYP34a inducers or inhibitors (such as erythromycin, ketoconazole, phenobarbital, rifampin)
- Significant mental or chronic systemic illnesses that may impact pain assessment
- Breast feeding, giving birth within the last 6 months, pregnancy, or planning to become pregnant in the next 12 month
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Efficacy of the Levonorgestrel Intrauterine Device With Norethindrone Acetate for Treatment of Endometriosis in Adolescents and Young Adults
Endometriosis is the most common reproductive disease afflicting young women, often leading to debilitating chronic pelvic pain and impaired quality of life. Safe, effective, and convenient long-term treatments are lacking for adolescents and young adults. The levonorgestrel-containing IUD (LNG-IUD) represents an attractive long-term drug delivery system for the treatment of endometriosis during adolescence and young adulthood. However, while the LNG-IUD has an acceptable safety profile, it is not associated with a favorable bleeding profile and may not fully suppress endometriosis pain when used as monotherapy. Investigators hypothesize that the addition of NETA will improve bleeding patterns, maximize pain control, and improve continuation rates of the IUD when the two medications are used in combination. This proposed prospective trial provides the ideal context in which to investigate these clinical questions and advance research on the best treatments for endometriosis.
Read the detailed description
Endometriosis is a major source of morbidity for U.S. females, affecting ~49% of adolescents with chronic pelvic pain and 10% of all women of reproductive age. This percentage translates into approximately 176 million women worldwide who may suffer from endometriosis. Annual health care costs are estimated to be over $22 billion in the US alone. Over 50% of adults with endometriosis report onset of severe pelvic pain during their adolescence. Symptoms result in decreased quality of life, negative socioeconomic consequences, impaired reproductive potential, and diminished mental health. Endometriosis is a chronic disease that progresses over time in more than half of patients. Endometriosis has no cure. For adolescents in particular, this means that the impact of endometriosis and its symptoms can last for decades. Appropriate management involves not only prompt initiation of therapy, but also the maintenance of therapy for a protracted length of time.
Medical therapy for endometriosis typically includes oral progestins or contraceptive pills. Though often effective, these options are associated with systemic side-effects which may further affect compliance and preclude long-term use. Furthermore, the need for repeated or regular administration compromises compliance and therefore efficacy. The levonorgestrel-releasing intrauterine system (LNG-IUD) has been evaluated as a promising treatment for endometriosis in adult women. The LNG-IUD 52 mg (Mirena) delivers levonorgestrel (LNG) to the uterine cavity at a steady rate of 20 µg/day over 5 to 6 years. The LNG causes atrophy and pseudo decidualization of the uterine lining, along with apoptosis of endometrial glands and stroma. As the LNG-IUD requires no further patient action following insertion, patient compliance is excellent. While continuation of the device is generally very good in adults, unfavorable uterine bleeding patterns are the most frequent reason for early device removal, particularly within the first 6 months. Anecdotal clinical experience suggests that combining use of the LNG-IUD with low-dose oral progestin therapy may maximize effectiveness and continuation of the LNG-IUD device in adolescents.
The investigators will recruit 80 adolescents for participation in a double-blind, randomized trial of NETA (n=40) vs. placebo (control group, n=40) for adjunct treatment to the levonorgestrel-containing IUD for pelvic pain due to endometriosis. It is believed that a combination of the locally-acting LNG-IUD plus systemic NETA may be the optimal combination to effectively treat endometriosis pain, minimize side effects, provide contraception, and control bleeding for adolescents with endometriosis.
- Conditions
- Endometriosis
- Being tested
- norethindrone acetate (NETA), Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norethindrone acetate (NETA)Drug
Also called Aygestin
5mg of the NETA capsule by mouth daily for 12 months
PlaceboDrug
Also called gelatin capsules- filled with lactose monohydrate (0.2 gram)
Placebo capsule everyday for 12 months
| Study group | Role | What they receive |
|---|---|---|
| LNG IUD+ Norethindrone Acetate | Experimental | All eligible participants will have the LNG-IUD. Experimental participants will also receive norethindrone acetate 5 mg by mouth daily for 12 months. Receives: Drug: norethindrone acetate (NETA) |
| LNG IUD+Placebo | Placebo comparator | All eligible participants will have the LNG-IUD. Participants in the placebo comparator group will also receive a placebo tablet, 1 tablet by mouth daily for 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain-Physical functioning assessed by the BPI
A 7-item self-report measure. The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assesses the extent to which pain interferes with sleep. Either the item asking about the "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference. The BPI is anchored between a scale of zero (no pain/interference) to ten (maximum pain/interference). The magnitude of treatment-associated change in BPI Interference Scale scores in open-label and randomized clinical trials ranges from 1 to 3 points, depending on the specific pain conditions and treatments studied.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Change in pain severity measured by Visual Analog Scale (VAS)
VAS: A measurement of pain intensity, assessed by a 0 to 10 numerical rating scale, to rate maximum and average pain intensity over the preceding 7 days. Higher scores indicate more severe pain intensity.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Change in pain measured by Biberoglu and Behrman patient ratings scale (B&B pain scale)
Biberoglu and Behrman patient ratings scale (B\&B pain scale): Survey that assesses dyspareunia, dysmenorrhea, and noncyclic pelvic pain. Each is graded on a scale from 0 to 3, with higher numbers indicating more severe symptoms.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Change in Emotional functioning, assessed by the Beck Depression Inventory-II (BDI)
Beck Depression Inventory-II (BDI)130, a 21-item self-report instrument that provides a rapid assessment of depressive symptoms.Total scores on the BDI range from 0 to 63. Scores below 10 should be considered to reflect "minimal or no" depression, with score ranges of 10 to 18, 19 to 29, and 30 to 63 reflect "mild to moderate," "moderate to severe," and "severe" depression, respectively.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Change in Participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale (PGIC)
This single-item self-assessed rating uses a 7-point rating scale with the options "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," and "very much worse."
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Secondary outcomes (12)
Change in high sensitivity C-reactive protein
investigators will measure changes in high sensitivity C-reactive protein (mg/L) over time to determine whether norethindrone acetate impacts inflammatory markers.
Measured: Baseline, 6 months, 12 months
Change in interleukin-8
Investigators will measure changes in interleukin-8 (pg/mL) over time to determine whether norethindrone acetate impacts inflammatory markers.
Measured: Baseline, 6 months, 12 months
Change in tumor necrosis factor alpha
Investigators will measure tumor necrosis factor alpha (pg/mL) to determine whether norethindrone acetate impacts inflammatory markers.
Measured: Baseline, 6 months, 12 months
Change in Tissue factor pathway inhibitor (TFPI)
Investigators will measure changes in TFPI to determine whether norethindrone acetate impacts prothrombotic markers.
Measured: Baseline, 6 months, 12 months
Change in von Willebrand factor antigen
Investigators will measure changes in von Willebrand factor antigen to determine whether norethindrone acetate impacts prothrombotic markers (VWFpp) to VWF antigen (VWF:Ag).
Measured: Baseline, 6 months, 12 months
Change in Factor VIII activity
Investigators will measure changes in Factor VIII activity (1 U/mL) to determine whether norethindrone acetate impacts prothrombotic markers.
Measured: Baseline, 6 months, 12 months
Change in soluble P-selectin
Investigators will measure changes in soluble P- selectin (unit) over time to determine whether norethindrone acetate impacts prothrombotic markers.
Measured: Baseline, 6 months, 12 months
Change in interleukin-6 (IL-6)
Investigators will measure changes in interleukin-6 (pg/mL) over time to determine whether norethindrone acetate impacts prothrombotic markers.
Measured: Baseline, 6 months, 12 months
Change in lipoprotein[a]
Investigators will measure changes in lipoprotein[a] (mg/dL) over time to determine whether norethindrone acetate impacts prothrombotic markers.
Measured: Baseline, 6 months, 12 months
Change in Measure of arterial stiffness by pulse wave velocity
Pulse wave velocity is an ultrasound measurement of the rate at which pressure waves move down a blood vessel. It is collected by using two pressure monitors placed a known distance from one another, the "Pulse Wave Distance". Pulse wave velocity is a validated surrogate measure of arterial stiffness that is a novel biomarker for cardiovascular risk/dysfunction.
Measured: Baseline, 12 months
Change in Bone mineral density Z-scores by dual energy Xray absorptiometry (DXA)
DXA has been the most widely used tool for the assessment of bone mass in clinical practice. DXA measures bone in two dimensions, and allows for the calculation of aBMD. Although these measures do not capture the internal architecture of bone, they are highly correlated with bone strength. A DXA scan of the total body (less head), lumbar spine, and total hip will be obtained. Age-, race-, and gender-specific Z-scores will be calculated using appropriate reference software.
Measured: Baseline, 6 months, 12 months
Change in measures of central hypersensitization measured by quantitative sensory testing.
The Quantitative sensory testing (QST) is a standard method through which sensory nerve function is quantitatively measured, based on responses of the participant. It will be measured at the abdomen, as well as the arm, which serves as an internal control.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jan 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Why it stopped: No funding
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.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will recruit 80 adolescents for participation in a double-blind, randomized trial of NETA (n=40) vs. placebo (control group, n=40) for adjunct treatment to the levonorgestrel-containing IUD for pelvic pain due to endometriosis.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy DiVasta, MD, Boston Children's Hospital
- Investigators
- Amy DiVasta, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948489
- Sponsor's protocol ID
- IRB-P00037934
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Levonorgestrel Intrauterine Device With Norethindrone Acetate for Treatment of Endometriosis in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT04948489
- Acronym / sponsor ID
- IRB-P00037934
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 2 Jul 2021 (actual)
- 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 the most common reproductive disease afflicting young women, often leading to debilitating chronic pelvic pain and impaired quality of life. Safe, effective, and convenient long-term treatments are lacking for adolescents and young adults. The levonorgestrel-containing IUD (LNG-IUD) represents an attractive long-term drug delivery system for the treatment of endometriosis during adolescence and young adulthood. However, while the LNG-IUD has an acceptable safety profile, it is not associated with a favorable bleeding profile and may not fully suppress endometriosis pain when used as monotherapy. Investigators hypothesize that the addition of NETA will improve bleeding patterns, maximize pain control, and improve continuation rates of the IUD when the two medications are used in combination. This proposed prospective trial provides the ideal context in which to investigate these clinical questions and advance research on the best treatments for endometriosis.
Detailed description
Endometriosis is a major source of morbidity for U.S. females, affecting ~49% of adolescents with chronic pelvic pain and 10% of all women of reproductive age. This percentage translates into approximately 176 million women worldwide who may suffer from endometriosis. Annual health care costs are estimated to be over $22 billion in the US alone. Over 50% of adults with endometriosis report onset of severe pelvic pain during their adolescence. Symptoms result in decreased quality of life, negative socioeconomic consequences, impaired reproductive potential, and diminished mental health. Endometriosis is a chronic disease that progresses over time in more than half of patients. Endometriosis has no cure. For adolescents in particular, this means that the impact of endometriosis and its symptoms can last for decades. Appropriate management involves not only prompt initiation of therapy, but also the maintenance of therapy for a protracted length of time.
Medical therapy for endometriosis typically includes oral progestins or contraceptive pills. Though often effective, these options are associated with systemic side-effects which may further affect compliance and preclude long-term use. Furthermore, the need for repeated or regular administration compromises compliance and therefore efficacy. The levonorgestrel-releasing intrauterine system (LNG-IUD) has been evaluated as a promising treatment for endometriosis in adult women. The LNG-IUD 52 mg (Mirena) delivers levonorgestrel (LNG) to the uterine cavity at a steady rate of 20 µg/day over 5 to 6 years. The LNG causes atrophy and pseudo decidualization of the uterine lining, along with apoptosis of endometrial glands and stroma. As the LNG-IUD requires no further patient action following insertion, patient compliance is excellent. While continuation of the device is generally very good in adults, unfavorable uterine bleeding patterns are the most frequent reason for early device removal, particularly within the first 6 months. Anecdotal clinical experience suggests that combining use of the LNG-IUD with low-dose oral progestin therapy may maximize effectiveness and continuation of the LNG-IUD device in adolescents.
The investigators will recruit 80 adolescents for participation in a double-blind, randomized trial of NETA (n=40) vs. placebo (control group, n=40) for adjunct treatment to the levonorgestrel-containing IUD for pelvic pain due to endometriosis. It is believed that a combination of the locally-acting LNG-IUD plus systemic NETA may be the optimal combination to effectively treat endometriosis pain, minimize side effects, provide contraception, and control bleeding for adolescents with endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Investigators will recruit 80 adolescents for participation in a double-blind, randomized trial of NETA (n=40) vs. placebo (control group, n=40) for adjunct treatment to the levonorgestrel-containing IUD for pelvic pain due to endometriosis.
| Arm | Type | Receives |
|---|---|---|
| LNG IUD+ Norethindrone Acetate | Experimental | Drug: norethindrone acetate (NETA)All eligible participants will have the LNG-IUD. Experimental participants will also receive norethindrone acetate 5 mg by mouth daily for 12 months. |
| LNG IUD+Placebo | Placebo comparator | Drug: PlaceboAll eligible participants will have the LNG-IUD. Participants in the placebo comparator group will also receive a placebo tablet, 1 tablet by mouth daily for 12 months. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female with surgically confirmed endometriosis
- Clinical decision to begin use of the LNG-IUD
- Age 13 to 24 years
- Current pelvic pain (score ≥ 3 on Visual Analog Scale) that has been present for at least 2 months prior to enrollment
- Willingness to comply with visit schedule and study protocol
Key exclusion criteria (11 listed)
- Pre-menarche or post-menopause
- Previous gonadotropin-releasing agonist use
- Contraindications to an IUD (e.g., cavity-distorting uterine anomaly, acute pelvic inflammatory disease, <3 months from postpartum endometritis or septic abortion, local neoplasm, uterine bleeding of unknown etiology, breast cancer, untreated cervicitis or vaginitis or other lower genital tract infections)
- Active or historical venous thromboembolism, active or recent arterial thromboembolic disease
- Impaired liver function or liver disease
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 |
|---|---|---|
| norethindrone acetate (NETA)Also: Aygestin5mg of the NETA capsule by mouth daily for 12 months | Drug | LNG IUD+ Norethindrone Acetate |
| PlaceboAlso: gelatin capsules- filled with lactose monohydrate (0.2 gram)Placebo capsule everyday for 12 months | Drug | LNG IUD+Placebo |
Primary outcome
Change in Pain-Physical functioning assessed by the BPI
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
A 7-item self-report measure. The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assesses the extent to which pain interferes with sleep. Either the item asking about the "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference. The BPI is anchored between a scale of zero (no pain/interference) to ten (maximum pain/interference). The magnitude of treatment-associated change in BPI Interference Scale scores in open-label and randomized clinical trials ranges from 1 to 3 points, depending on the specific pain conditions and treatments studied.
Change in pain severity measured by Visual Analog Scale (VAS)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
VAS: A measurement of pain intensity, assessed by a 0 to 10 numerical rating scale, to rate maximum and average pain intensity over the preceding 7 days. Higher scores indicate more severe pain intensity.
Change in pain measured by Biberoglu and Behrman patient ratings scale (B&B pain scale)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Biberoglu and Behrman patient ratings scale (B\&B pain scale): Survey that assesses dyspareunia, dysmenorrhea, and noncyclic pelvic pain. Each is graded on a scale from 0 to 3, with higher numbers indicating more severe symptoms.
Change in Emotional functioning, assessed by the Beck Depression Inventory-II (BDI)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Beck Depression Inventory-II (BDI)130, a 21-item self-report instrument that provides a rapid assessment of depressive symptoms.Total scores on the BDI range from 0 to 63. Scores below 10 should be considered to reflect "minimal or no" depression, with score ranges of 10 to 18, 19 to 29, and 30 to 63 reflect "mild to moderate," "moderate to severe," and "severe" depression, respectively.
Change in Participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale (PGIC)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
This single-item self-assessed rating uses a 7-point rating scale with the options "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," and "very much worse."
12 secondary outcomes
Change in high sensitivity C-reactive protein
Time frame: Baseline, 6 months, 12 months
Change in interleukin-8
Time frame: Baseline, 6 months, 12 months
Change in tumor necrosis factor alpha
Time frame: Baseline, 6 months, 12 months
Change in Tissue factor pathway inhibitor (TFPI)
Time frame: Baseline, 6 months, 12 months
Change in von Willebrand factor antigen
Time frame: Baseline, 6 months, 12 months
Change in Factor VIII activity
Time frame: Baseline, 6 months, 12 months
Change in soluble P-selectin
Time frame: Baseline, 6 months, 12 months
Change in interleukin-6 (IL-6)
Time frame: Baseline, 6 months, 12 months
Change in lipoprotein[a]
Time frame: Baseline, 6 months, 12 months
Change in Measure of arterial stiffness by pulse wave velocity
Time frame: Baseline, 12 months
Change in Bone mineral density Z-scores by dual energy Xray absorptiometry (DXA)
Time frame: Baseline, 6 months, 12 months
Change in measures of central hypersensitization measured by quantitative sensory testing.
Time frame: Baseline, 6 months, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Amy DiVasta principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing norethindrone acetate (NETA) in people with Endometriosis, run by Boston Children's Hospital at 1 site in United States.
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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 21 Mar 2025. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 withdrawn before enrolling participants, so there are no results.
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?
Change in Pain-Physical functioning assessed by the BPI (time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months). The study lists 5 primary outcomes in all. 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 21 Mar 2025.