DFDA

Elagolix + Estradiol/Norethindrone Acetate

Treatment for Uterine Fibroids

Typical Dosage: Elagolix 300mg daily, Estradiol 1mg / Norethindrone Acetate 0.5mg daily

Effectiveness
85%
Safety Score
60%
Clinical Trials
9
Participants
3K

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
60
DangerousModerateSafe
Treatment Details
Dosage Range
Elagolix 300mg daily, Estradiol 1mg / Norethindrone Acetate 0.5mg daily
Time to Effect
1-2 months
Treatment Duration
Up to 24 months
Evidence Quality
HIGH
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$16,000
Monitoring:$500
Side Effect Mgmt:$200
Total Annual:$16,700
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POOR
ICER
$250,000/QALY
QALYs Gained
0.2
Outcome-Based Costs
Cost per Responder
$22,267
Cost per Remission
$111,333
Comparison vs Watchful Waiting
Cost Difference
+$16,700/year
More expensive
QALY Difference
+0.20 QALYs
Better outcomes
Dominance
No dominance
Elagolix + Estradiol/Norethindrone Acetate Outcomes

for Uterine Fibroids

Efficacy Outcomes
Overall Effectiveness
+85%
Response Rate
+75%
Remission Rate
+15%
Common Side Effects
Hot flashes
+60%
Headache
+25%
Nausea
+12%
Joint pain
+10%
Decreased bone mineral density (mitigated with add-back)
+5%

Sources:

oriahnn.com
researchgate.net
nih.gov

WARNING: LIMITED TRIALS AVAILABLE

You can search for trials, but you probably can't join any because the 1% Treaty hasn't passed yet. Most trials are severely limited by lack of funding and bureaucratic barriers. Help change this!

Active Clinical Trials
No active trials currently recruiting for this treatment

No active trials found in ClinicalTrials.gov

Completed Clinical Trials
6 completed trials for Elagolix + Estradiol/Norethindrone Acetate in Uterine Fibroids

An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

NCT02925494COMPLETEDPHASE3
View Study
433 participants
INTERVENTIONAL
Birmingham, United States +123 more
Started: Sep 14, 2016

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

NCT02654054COMPLETEDPHASE3
View Study
413 participants
INTERVENTIONAL
Birmingham, United States +95 more
Started: Dec 22, 2015

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

NCT02691494COMPLETEDPHASE3
View Study
378 participants
INTERVENTIONAL
Birmingham, United States +104 more
Started: Feb 3, 2016

Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

NCT01441635COMPLETEDPHASE2
View Study
271 participants
INTERVENTIONAL
Started: Sep 8, 2011

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

NCT03271489COMPLETEDPHASE3
View Study
478 participants
INTERVENTIONAL
Birmingham, United States +156 more
Started: Sep 13, 2017

Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

NCT01817530COMPLETEDPHASE2
View Study
571 participants
INTERVENTIONAL
Started: Apr 8, 2013