Condition

Uterine fibroids

Clinical trials and treatment information for Uterine fibroids

119.5M
People Affected
60
Active Trials
3.6M
New Cases/Year
2,078
Deaths/Year

Treatment Rankings

Ranked by evidence volume first. Medicine has spent centuries ranking things by vibes. This is an improvement.

1
Hysterectomy
100% Effectiveness• 95% Confidence• 45% Safety• 56 trials• 1M participants
HIGH EvidenceExcellent Value
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Comparative Safety Scale(Higher is safer)

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45
DangerousModerateSafe

Time to Effect

Immediate post-recovery (4-8 weeks)

Duration

One-time procedure

Response Rate

100%

Remission Rate

100%

Common Side Effects:

Post-operative pain: 90%
Infection: 10%
Bleeding: 8%
Organ injury: 2%

Annual Cost of Care

Drug Cost

$0

Monitoring

$500

Side Effects

$0

Total Annual

$500

Cost-Effectiveness

EXCELLENT

QALYs Gained

1.5

ICER

$50,000/QALY

Cost per Remission

$20,000

Cost per Responder

$20,000

Treatment Outcomes
Primary Outcomes
Menstrual Blood Loss Severity (PBAC score)180 (Pictorial Blood Assessment Chart, >100 indicates menorrhagia)
-100% (-180 points (complete cessation))
Uterine Fibroid Symptom Severity (UFS-QOL Symptom Score)65/100 (higher score indicates worse symptoms)
-85% (-55 points)
Pelvic Pressure/Bulk Symptoms (UFS-QOL Bulk Symptoms Scale)70/100 (higher score indicates worse symptoms)
-80% (-56 points)
Hemoglobin (Hb) Levels9.8 g/dL (anemic threshold <12 g/dL)
+22.4% (+2.2 g/dL)
Secondary Benefits
Health-Related Quality of Life (UFS-QOL HRQOL Score)40/100 (higher score indicates better QOL)
+90% (+36 points)
Dyspareunia Severity (NRS score)6/10 (Numerical Rating Scale)
-66.7% (-4 points)
Urinary Frequency (episodes/day)12 episodes/day
-58.3% (-7 episodes/day)
Common Side Effects
Post-operative pain
+90%
Infection
+10%
Bleeding
+8%

Clinical Trial Phases:

Phase 4
2
Myomectomy
90% Effectiveness• 90% Confidence• 50% Safety• 101 trials• 50K participants
HIGH EvidenceGood Value
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Comparative Safety Scale(Higher is safer)

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50
DangerousModerateSafe

Time to Effect

Immediate post-recovery (2-8 weeks)

Duration

One-time procedure

Response Rate

90%

Remission Rate

%

Common Side Effects:

Post-operative pain: 85%
Infection: 7%
Bleeding: 6%
Adhesions: 30%

Annual Cost of Care

Drug Cost

$0

Monitoring

$500

Side Effects

$0

Total Annual

$500

Cost-Effectiveness

GOOD

QALYs Gained

1

ICER

$80,000/QALY

Cost per Responder

$16,667

Treatment Outcomes
Primary Outcomes
Menstrual Blood LossPictorial Blood Loss Assessment Chart (PBAC) score: 250
-70% (-175 points)
Pelvic Pain SeverityNumeric Rating Scale (NRS) for pain: 7/10
-57.1% (-4 points)
Uterine Volume450 cm³
-60% (-270 cm³)
Clinical Pregnancy Rate (for subfertile patients)10%
+300% (+30 percentage points)
Secondary Benefits
Health-Related Quality of LifeUterine Fibroid Symptom and Quality of Life (UFS-QOL) HRQOL score: 40/100
+50% (+20 points)
Hemoglobin Level (for anemia resolution)10.5 g/dL
+19% (+2.0 g/dL)
Sexual FunctionFemale Sexual Function Index (FSFI) total score: 20/36
+30% (+6 points)
Common Side Effects
Post-operative pain
+85%
Infection
+7%
Bleeding
+6%

Clinical Trial Phases:

Phase 4
3
Uterine Artery Embolization (UAE)
88% Effectiveness• 90% Confidence• 55% Safety• 13 trials• 30K participants
HIGH EvidenceGood Value
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55
DangerousModerateSafe

Time to Effect

Weeks to 3 months

Duration

One-time procedure

Response Rate

75%

Remission Rate

%

Common Side Effects:

Post-embolization syndrome (pain, fever, nausea): 80%
Vaginal discharge: 15%
Amenorrhea: 8%
Infection: 3%

Annual Cost of Care

Drug Cost

$0

Monitoring

$500

Side Effects

$0

Total Annual

$500

Cost-Effectiveness

GOOD

QALYs Gained

0.9

ICER

$90,000/QALY

Cost per Responder

$13,333

Treatment Outcomes
Primary Outcomes
Uterine Fibroid Symptom Severity (UFS-QOL Symptom Severity subscale)60 points (0-100 scale, higher is worse)
-60% (-36 points)
Menstrual Blood Loss (PBAC Score)250 points (e.g., for menorrhagia, >100 is heavy bleeding)
-60% (-150 points)
Uterine Volume350 cm³
-40% (-140 cm³)
Dominant Fibroid Volume200 cm³
-50% (-100 cm³)
Secondary Benefits
Uterine Fibroid Symptom Quality of Life (UFS-QOL HRQL subscale)40 points (0-100 scale, higher is better)
+50% (+20 points)
Hemoglobin11.0 g/dL (mild anemia due to blood loss)
+10% (+1.1 g/dL)
Pelvic Pain Severity (VAS Score)6/10 (0-10 scale)
-50% (-3/10)
Common Side Effects
Post-embolization syndrome (pain, fever, nausea)
+80%
Vaginal discharge
+15%
Amenorrhea
+8%

Clinical Trial Phases:

Phase 4
4
Elagolix + Estradiol/Norethindrone Acetate
85% Effectiveness• 90% Confidence• 60% Safety• 9 trials• 3K participants
HIGH EvidencePoor ValueDose: Elagolix 300mg daily, Estradiol 1mg / Norethindrone Acetate 0.5mg daily
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Comparative Safety Scale(Higher is safer)

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60
DangerousModerateSafe

Time to Effect

1-2 months

Duration

Up to 24 months

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%

Annual Cost of Care

Drug Cost

$16,000

Monitoring

$500

Side Effects

$200

Total Annual

$16,700

Cost-Effectiveness

POOR

QALYs Gained

0.2

ICER

$250,000/QALY

Cost per Remission

$111,333

Cost per Responder

$22,267

Treatment Outcomes
Primary Outcomes
Menstrual Blood Loss Volume250 mL/cycle
-70% (-175 mL/cycle)
UFS-QOL Symptom Severity Score60 points (0-100 scale, higher is worse)
-58.3% (-35 points)
Hemoglobin Level10.5 g/dL
+14.3% (+1.5 g/dL)
Secondary Benefits
Dysmenorrhea Severity (NRS)7.5 (0-10 scale, higher is worse)
-60% (-4.5 points)
UFS-QOL Health-Related Quality of Life Score45 points (0-100 scale, higher is better)
+77.8% (+35 points)
Uterine Volume220 cm³
-15% (-33 cm³)
Common Side Effects
Hot flashes
+60%
Headache
+25%
Nausea
+12%

Clinical Trial Phases:

Phase 3Phase 4
5
Radiofrequency Ablation (RFA)
80% Effectiveness• 80% Confidence• 60% Safety• 15 trials• 5K participants
MODERATE EvidenceGood Value
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60
DangerousModerateSafe

Time to Effect

1-3 months

Duration

One-time procedure

Response Rate

80%

Remission Rate

%

Common Side Effects:

Post-procedure pain: 60%
Cramping: 40%
Vaginal discharge: 8%
Infection: 1%

Annual Cost of Care

Drug Cost

$0

Monitoring

$500

Side Effects

$0

Total Annual

$500

Cost-Effectiveness

GOOD

QALYs Gained

0.7

ICER

$120,000/QALY

Cost per Responder

$15,000

Treatment Outcomes
Primary Outcomes
Pictorial Blood Loss Assessment Chart (PBAC) Score250 (score >100 indicates menorrhagia)
-70% (-175 points)
Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QOL) Symptom Severity Score75/100 (higher score = worse symptoms)
-50% (-37.5 points)
Dominant Fibroid Volume60 cm³
-60% (-36 cm³)
Total Uterine Volume250 cm³
-35% (-87.5 cm³)
Secondary Benefits
Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QOL) Health-Related Quality of Life Score45/100 (higher score = better QOL)
+67% (+30 points)
Dysmenorrhea Visual Analog Scale (VAS) Score7/10 (0=no pain, 10=worst pain)
-57% (-4 points)
Pelvic Pressure/Bloating Severity (0-4 scale)3/4 (higher score = more severe)
-67% (-2 points)
Common Side Effects
Post-procedure pain
+60%
Cramping
+40%
Vaginal discharge
+8%

Clinical Trial Phases:

Phase 3Phase 4
6
Leuprolide (GnRH Agonist)
80% Effectiveness• 90% Confidence• 55% Safety• 4 trials• 15K participants
HIGH EvidenceModerate ValueDose: 3.75 mg IM monthly
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Comparative Safety Scale(Higher is safer)

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55
DangerousModerateSafe

Time to Effect

1-2 months

Duration

3-6 months (pre-surgical) or up to 12 months with add-back therapy

Response Rate

85%

Remission Rate

%

Number Needed to Treat (NNT)

3

Common Side Effects:

Hot flashes: 80%
Vaginal dryness: 50%
Mood changes: 30%
Headache: 25%
Decreased bone mineral density (if prolonged): 10%

Annual Cost of Care

Drug Cost

$2,000

Monitoring

$300

Side Effects

$300

Total Annual

$2,600

Cost-Effectiveness

MODERATE

QALYs Gained

0.1

Cost per Responder

$3,059

Treatment Outcomes
Primary Outcomes
Uterine Volume250 cm³
-40% (-100 cm³)
Total Fibroid Volume200 cm³
-45% (-90 cm³)
Menstrual Blood Loss (PBAC Score)PBAC score: 250 points
-80% (-200 points)
Hemoglobin10.5 g/dL
+15% (+1.6 g/dL)
Secondary Benefits
Pelvic Pain (VAS Score)VAS score: 7/10
-50% (-3.5 points)
UFS-QOL Symptom Severity ScoreUFS-QOL Symptom Severity Score: 50/100
-30% (-15 points)
Endometrial Thickness12 mm
-70% (-8.4 mm)
Common Side Effects
Hot flashes
+80%
Vaginal dryness
+50%
Mood changes
+30%

Clinical Trial Phases:

Phase 3Phase 4