Heavy Uterine BleedingPhase 2NCT01817530
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
A Phase 2 study testing Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate and 1 mg estradiol / 0.5 mg norethindrone acetate in people with Heavy Uterine Bleeding and Uterine Fibroids, run by AbbVie.
Trial summary
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Heavy Uterine Bleeding, Uterine Fibroids
- What is being tested?
- Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate and 1 mg estradiol / 0.5 mg norethindrone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 571 participants
- Where
- No sites listed yet
- Study dates
- 8 Apr 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is pre-menopausal female 18 to 51 years of age at Screening.
- Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
- Subject has heavy uterine bleeding associated with uterine fibroids.
Who cannot join
- Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
- Subject has a history of osteoporosis or other metabolic bone disease.
- Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
- Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
About this study
Official title: A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
- Conditions
- Heavy Uterine Bleeding, Uterine Fibroids
- Being tested
- Elagolix placebo, Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate, 1 mg estradiol / 0.5 mg norethindrone acetate, E2/NETA placebo
- Keywords
- Uterine Fibroids, Leiomyomata, Elagolix, Menorrhagia, Elagolix sodium, Heavy Uterine Bleeding, ABT-620
- Medical subject headings
- Leiomyoma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elagolix placeboOther
oral coated tablet
ElagolixDrug
Also called ABT-620
oral coated tablet
0.5 mg estradiol / 0.1 mg norethindrone acetateDrug
Also called Activelle, Activella, low dose (LD) E2/NETA
oral hard capsule
1 mg estradiol / 0.5 mg norethindrone acetateDrug
Also called Activelle, Activella, standard dose (SD) E2/NETA
oral hard capsule
E2/NETA placeboDrug
oral hard capsule
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Placebo | Placebo comparator | Placebo for elagolix and placebo for E2/NETA twice daily (BID) Receives: Other: Elagolix placebo; Drug: E2/NETA placebo |
| Cohort 1: Elagolix 300 mg BID | Experimental | Elagolix 300 mg BID alone Receives: Drug: Elagolix; Drug: E2/NETA placebo |
| Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD | Experimental | Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD) Receives: Drug: Elagolix; Drug: 0.5 mg estradiol / 0.1 mg norethindrone acetate |
| Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD | Experimental | Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD Receives: Drug: Elagolix; Drug: 1 mg estradiol / 0.5 mg norethindrone acetate |
| Cohort 2: Placebo | Placebo comparator | Placebo for elagolix and E2/NETA QD Receives: Other: Elagolix placebo; Drug: E2/NETA placebo |
| Cohort 2: Elagolix 600 mg QD | Experimental | Elagolix 600 mg QD alone Receives: Drug: Elagolix; Drug: E2/NETA placebo |
| Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD | Experimental | Elagolix 600 mg QD plus LD E2/NETA QD Receives: Drug: Elagolix; Drug: 0.5 mg estradiol / 0.1 mg norethindrone acetate |
| Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD | Experimental | Elagolix 600 mg QD plus SD E2/NETA QD Receives: Drug: Elagolix; Drug: 1 mg estradiol / 0.5 mg norethindrone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of < 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Measured: Baseline, Final Month (last 28 days of treatment)
Secondary outcomes (18)
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
Measured: Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
Measured: Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)
Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month
Percentage of participants who achieved an MBL volume of < 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Measured: Final Month (last 28 days of treatment)
Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
Percentage of participants with a >= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Measured: Baseline, Final Month (last 28 days of treatment)
Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment
Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment.
Measured: Last 56 days of treatment (after 10 days from first dose date)
Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment
Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment.
Measured: Last 56 days of treatment (after 10 days from first dose date)
Mean Change in the Number of Bleeding Days From Baseline to Month 6
The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
Measured: Baseline, Month 6
Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6
The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
Measured: Baseline, Month 6
Change in Bleeding Severity Scores From Baseline at the Final Month
The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug.
Measured: Baseline, Final Month (last 28 days of treatment)
Mean Change in Hemoglobin Concentration From Baseline to Final Visit
Baseline is defined as the last measurement prior to the first dose of study drug.
Measured: Baseline, Final Visit during treatment period (Month 6 or early termination)
Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound.
Measured: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Volume of the largest fibroid (primary fibroid), as measured by transvaginal ultrasound, or transabdominal ultrasound.
Measured: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Uterine volume, as measured by transvaginal ultrasound or transabdominal ultrasound.
Measured: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Total fibroid volume (3 largest fibroids) was measured by transvaginal ultrasound, or transabdominal ultrasound.
Measured: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Volume of the largest fibroid (primary fibroid) was measured by transvaginal ultrasound or transabdominal ultrasound.
Measured: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Uterine volume was measured by transvaginal ultrasound or transabdominal ultrasound.
Measured: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
The NBUFSQ (8 items) is a brief patient-reported daily diary that assesses non-bleeding symptoms experienced by women with uterine fibroids. It includes 6 items, asking women to rate their symptoms (abdominal/pelvic pain, pressure, and cramping, back pain, bloating, and urinary problems) in the past 24 hours using an 11-point numeric response scale that ranges from 0 (i.e., no symptom) to 10 (i.e., worst possible symptom) and 2 items to address urinary frequency during the daytime and at night. Data presented in the sum of scores to the 6 symptom questions, ranging from 0 (no symptoms) to 60 (worst possible symptoms). Baseline is defined as the last 28 days prior to the first day of study drug. Final Month is defined as the last 28 days prior to and including the last dose date of study drug.
Measured: Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168
Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids
The percentage of participants who successfully avoided surgical or invasive procedures for Uterine Fibroids was assessed.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study start8 Apr 2013
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heavy Uterine BleedingStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlotte Owens, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817530
- Sponsor's protocol ID
- M12-813
- Other IDs
- 2013-000082-37
- Status last verified
- Jun 2020
- First submitted
- 21 Mar 2013
- Last updated
- 21 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Publications
Carr BR, Stewart EA, Archer DF, Al-Hendy A, Bradley L, Watts NB, Diamond MP, Gao J, Owens CD, Chwalisz K, Duan WR, Soliman AM, Dufek MB, Simon JA. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1252-1264. doi: 10.1097/AOG.0000000000002933.
PubMed 30303923
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- ClinicalTrials.gov ID
- NCT01817530
- Acronym / sponsor ID
- M12-813
- Conditions
- Heavy Uterine Bleeding, Uterine Fibroids
- Keywords
- Uterine Fibroids, Leiomyomata, Elagolix, Menorrhagia, Elagolix sodium, Heavy Uterine Bleeding, ABT-620
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Posted 21 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Placebo | Placebo comparator | Other: Elagolix placebo, Drug: E2/NETA placeboPlacebo for elagolix and placebo for E2/NETA twice daily (BID) |
| Cohort 1: Elagolix 300 mg BID | Experimental | Drug: Elagolix, Drug: E2/NETA placeboElagolix 300 mg BID alone |
| Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD | Experimental | Drug: Elagolix, Drug: 0.5 mg estradiol / 0.1 mg norethindrone acetateElagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD) |
| Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD | Experimental | Drug: Elagolix, Drug: 1 mg estradiol / 0.5 mg norethindrone acetateElagolix 300 mg BID plus standard-dose (SD) E2/NETA QD |
| Cohort 2: Placebo | Placebo comparator | Other: Elagolix placebo, Drug: E2/NETA placeboPlacebo for elagolix and E2/NETA QD |
| Cohort 2: Elagolix 600 mg QD | Experimental | Drug: Elagolix, Drug: E2/NETA placeboElagolix 600 mg QD alone |
| Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD | Experimental | Drug: Elagolix, Drug: 0.5 mg estradiol / 0.1 mg norethindrone acetateElagolix 600 mg QD plus LD E2/NETA QD |
| Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD | Experimental | Drug: Elagolix, Drug: 1 mg estradiol / 0.5 mg norethindrone acetateElagolix 600 mg QD plus SD E2/NETA QD |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is pre-menopausal female 18 to 51 years of age at Screening.
- Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
- Subject has heavy uterine bleeding associated with uterine fibroids.
Key exclusion criteria (4 listed)
- Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
- Subject has a history of osteoporosis or other metabolic bone disease.
- Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
- Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
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 |
|---|---|---|
| Elagolix placebooral coated tablet | Other | Cohort 1: Placebo, Cohort 2: Placebo |
| ElagolixAlso: ABT-620oral coated tablet | Drug | Cohort 1: Elagolix 300 mg BID, Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD, Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD, Cohort 2: Elagolix 600 mg QD, Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD, Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD |
| 0.5 mg estradiol / 0.1 mg norethindrone acetateAlso: Activelle, Activella, low dose (LD) E2/NETAoral hard capsule | Drug | Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD, Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD |
| 1 mg estradiol / 0.5 mg norethindrone acetateAlso: Activelle, Activella, standard dose (SD) E2/NETAoral hard capsule | Drug | Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD, Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD |
| E2/NETA placebooral hard capsule | Drug | Cohort 1: Elagolix 300 mg BID, Cohort 1: Placebo, Cohort 2: Elagolix 600 mg QD, Cohort 2: Placebo |
Primary outcome
Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
Time frame: Baseline, Final Month (last 28 days of treatment)
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of < 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
18 secondary outcomes
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment
Time frame: Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment
Time frame: Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)
Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month
Time frame: Final Month (last 28 days of treatment)
Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
Time frame: Baseline, Final Month (last 28 days of treatment)
Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment
Time frame: Last 56 days of treatment (after 10 days from first dose date)
Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment
Time frame: Last 56 days of treatment (after 10 days from first dose date)
Mean Change in the Number of Bleeding Days From Baseline to Month 6
Time frame: Baseline, Month 6
Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6
Time frame: Baseline, Month 6
Change in Bleeding Severity Scores From Baseline at the Final Month
Time frame: Baseline, Final Month (last 28 days of treatment)
Mean Change in Hemoglobin Concentration From Baseline to Final Visit
Time frame: Baseline, Final Visit during treatment period (Month 6 or early termination)
Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Time frame: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
Time frame: Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168
Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30303923Carr BR, Stewart EA, Archer DF, Al-Hendy A, Bradley L, Watts NB, Diamond MP, Gao J, Owens CD, Chwalisz K, Duan WR, Soliman AM, Dufek MB, Simon JA. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1252-1264. doi: 10.1097/AOG.0000000000002933.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
Charlotte Owens, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate and 1 mg estradiol / 0.5 mg norethindrone acetate in people with Heavy Uterine Bleeding and Uterine Fibroids, run by AbbVie.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 21 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month (time frame: Baseline, Final Month (last 28 days of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817530, which also lists 1 linked publication.
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 Jul 2020.