Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
Novartis Pharmaceuticals3,246 participants30 Nov 2016 to 9 Nov 2022
Breast Cancer
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated
Comparing 2 peptides · Data version 308560
Swipe sideways to see every peptide.
| Peptide | Synthetic analog Leuprolide | Natural peptide Oxytocin | |
|---|---|---|---|
| Identity | |||
| Kind | Synthetic analog | Natural peptide | |
| Area | Sexual health and hormones | Sexual health and hormones | |
| Evidence | |||
| Amount of evidence | 707 | 3,492 (plus 1,148 on natural levels, listed separately) | |
| Evidence level | Has results from studies in people | Has results from studies in people | |
| Safety | |||
| Safety results | 167 (167 in people) | 157 (152 in people) | |
| Status | |||
| Approval | |||
| Sport (WADA) | |||
| Registered trials | 393 · 85 active117 more mention it but do not test it | 690 · 65 active238 more mention it but do not test it | |
Shared outcomes
From the regulatory data of each peptide.
The FDA label for Leuprolide acetate for depot suspension says: “Selected three-month depot formulation for advanced prostate cancer”
Outcome groups with study results for at least two of these peptides. Counts include only results from studies that gave the peptide. Bar length is the number of results, on one scale. The bars show how much was studied, not how large an effect was. A peptide with more studies can look stronger here without being stronger. For results, see the randomized results above.
| Outcome group | Leuprolide | Oxytocin |
|---|---|---|
| Cognition and memoryNervous system and cognition | 13112 | 41440311 |
| Anxiety and mood |
PepBank is a research reference. Talk to a doctor before you use any peptide.
The FDA label for Pitocin says: “Antepartum: medically indicated induction of labor, stimulation or reinforcement of labor, adjunctive therapy in incomplete or inevitable abortion” No central EU authorisation (EMA).
1010 |
34132417 |
| Adverse eventsWhole body | 112112 | 1261233 |
|---|
| Sex hormones and fertilityReproductive and sexual health | 19616630 | 150328632 |
|---|
| PainSkin and wound | 3535 | 1098524 |
|---|
| Receptor activity and mechanismReproductive and sexual health | 1459 | 28960801472 |
|---|
| PharmacokineticsPharmacology | 341915 | 9168203 |
|---|
| Tumor growthReproductive and sexual health | 70682 | 6411 |
|---|
| Sexual functionReproductive and sexual health | 14122 | 7647245 |
|---|
| Bone and jointMusculoskeletal | 2525 | 2020 |
|---|
| Blood pressureCardiovascular | 211 | 5219249 |
|---|
| Bleeding and clottingReproductive and sexual health | 88 | 20182 |
|---|
Each analog against its native parent, residue by residue. Substitutions, non-standard residues and modifications are marked. Calculated from the two sequences.
Leuprolide differs from Gonadorelin at 2 positions.
What is different
For each outcome that two or more peptides have results for: the best result of a single randomized trial, on the same measure (the same kind of number, the same unit). When a trial has several dose arms, the cell shows the highest dose arm. The trials differ in people, length and dose, so a gap between two cells is not proof that one peptide works better.
| Outcome | Leuprolide | Oxytocin |
|---|---|---|
| Sex hormones and fertilityEndocrine and hormonesCompared as: value in the arm that got the peptide, in % | 82% Testosterone surge Dose studied: 7.5 mgn = 2692001 | 14.4% Mean percent change testosterone Dose studied: 24 IUn = 452020 |
| PainNervous system and cognitionCompared as: value in the arm that got the peptide, in score | −57.5 score Change in maximum VAS pelvic pain score Dose studied: 3.75 or 1.88 mg every 4 weeks24 weeksn not reported2022 |
82%
Testosterone surge
Dose studied: 7.5 mgn = 2692001
14.4%
Mean percent change testosterone
Dose studied: 24 IUn = 452020
The other peptides have no randomized result on the same measure, so these results cannot be set side by side.
| Outcome | Leuprolide | Oxytocin |
|---|---|---|
| PharmacokineticsPharmacologyCompared as: value in the arm that got the peptide, in effect size | No comparable result 11 randomized-trial results measure it in another way or another unit. | −1.12 effect size Effect size Dose studied: 48 IU/day6 weeksn = 1032020 |
2.53 score daily pain score Saline: 3.66 score Dose studied: 100 µgn = 52023 |
−57.5 score
Change in maximum VAS pelvic pain score
Dose studied: 3.75 or 1.88 mg every 4 weeks24 weeksn not reported2022
2.53 score
daily pain score
Saline: 3.66 score
Dose studied: 100 µgn = 52023
| Bleeding and clottingReproductive and sexual healthCompared as: value in the arm that got the peptide, in ml | No comparable result 6 randomized-trial results measure it in another way or another unit. | −508 ml Blood loss · Shown as a change. The study reports a blood loss of this size. Placebo group: −451 ml n = 942005 |
|---|
| Body weightMetabolic and weightCompared as: difference from placebo, in g | No comparable result 2 randomized-trial results measure it in another way or another unit. | 196 g Difference in total fat Dose studied: 24 IU four times daily8 weeksn = 612024 |
|---|
| Energy expenditure and thermogenesisMetabolic and weightCompared as: difference from placebo, in kcal/day | No comparable result 1 randomized-trial result measure it in another way or another unit. | −64 kcal/day Difference in resting energy expenditure Dose studied: 24 IU four times daily8 weeksn = 612024 |
|---|
| Anxiety and moodReproductive and sexual healthCompared as: value in the arm that got the peptide, in % | No comparable result 2 randomized-trial results measure it in another way or another unit. | −20% Score reduction · Shown as a change. The study reports a score reduction of this size. Placebo: −4% Dose studied: 20 IU twice daily in week 1, then 40 IU twice daily8 weeksn = 402013 |
|---|
| Sexual functionReproductive and sexual healthCompared as: value in the arm that got the peptide, in % | No comparable result 1 randomized-trial result measure it in another way or another unit. | 26% FSFI score change Placebo: 31% Dose studied: 32 IU8 weeksn = 302015 |
|---|
| Cognition and memoryNervous system and cognitionCompared as: difference from placebo, in sd | No comparable result 10 randomized-trial results measure it in another way or another unit. | 1.39 SD effect size n = 262017 |
|---|
| Exercise and physical functionNervous system and cognitionCompared as: difference from placebo, in kg | No comparable result 6 randomized-trial results measure it in another way or another unit. | 2.25 kg Whole body lean mass difference Dose studied: 24 IU 4 times per day8 weeksn = 212021 |
|---|
| LipidsCardiovascularCompared as: difference from placebo, in mg/dl | No comparable result 1 randomized-trial result measure it in another way or another unit. | −19.3 mg/dL LDL cholesterol change Dose studied: 24 IU 4 times per day8 weeksn = 212021 |
|---|
| Receptor activity and mechanismPharmacologyCompared as: value in the arm that got the peptide, in proteins | No comparable result 1 randomized-trial result measure it in another way or another unit. | 198 proteins Differentially expressed proteins Dose studied: 24 IUsingle dosen = 192026 |
|---|
No comparable result
11 randomized-trial results measure it in another way or another unit.
−1.12 effect size
Effect size
Dose studied: 48 IU/day6 weeksn = 1032020
No comparable result
6 randomized-trial results measure it in another way or another unit.
−508 ml
Blood loss · Shown as a change. The study reports a blood loss of this size.
Placebo group: −451 ml
n = 942005
No comparable result
2 randomized-trial results measure it in another way or another unit.
196 g
Difference in total fat
Dose studied: 24 IU four times daily8 weeksn = 612024
No comparable result
1 randomized-trial result measure it in another way or another unit.
−64 kcal/day
Difference in resting energy expenditure
Dose studied: 24 IU four times daily8 weeksn = 612024
No comparable result
2 randomized-trial results measure it in another way or another unit.
−20%
Score reduction · Shown as a change. The study reports a score reduction of this size.
Placebo: −4%
Dose studied: 20 IU twice daily in week 1, then 40 IU twice daily8 weeksn = 402013
No comparable result
1 randomized-trial result measure it in another way or another unit.
26%
FSFI score change
Placebo: 31%
Dose studied: 32 IU8 weeksn = 302015
No comparable result
10 randomized-trial results measure it in another way or another unit.
1.39 SD
effect size
n = 262017
No comparable result
6 randomized-trial results measure it in another way or another unit.
2.25 kg
Whole body lean mass difference
Dose studied: 24 IU 4 times per day8 weeksn = 212021
No comparable result
1 randomized-trial result measure it in another way or another unit.
−19.3 mg/dL
LDL cholesterol change
Dose studied: 24 IU 4 times per day8 weeksn = 212021
No comparable result
1 randomized-trial result measure it in another way or another unit.
198 proteins
Differentially expressed proteins
Dose studied: 24 IUsingle dosen = 192026
Registered trials, ranked by phase (late phases first), then posted results and enrollment. Status is the registry status. Study results come from published studies. Results posted at ClinicalTrials.gov are shown on each trial page.
Top 3 of 393 trials, ranked by phase, then posted results and enrollment: 1 ongoing · 2 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
Novartis Pharmaceuticals3,246 participants30 Nov 2016 to 9 Nov 2022
Breast Cancer
Radiation Therapy Oncology Group2,028 participantsOct 1994 to 14 May 2018
Prostate Cancer
SWOG Cancer Research Network1,939 participants12 Sept 2013 to est. Jan 2030
Breast Cancer
117 more mention it but do not test it. They only measure it or name it in their text.
Top 3 of 690 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
University of Alabama at Birmingham1,798 participantsNov 2008 to Jun 2010
Uterine Atony · Postpartum Hemorrhage
Northwestern University1,003 participants28 Sept 2015 to 28 Sept 2020
Dystocia
University of Zimbabwe506 participants8 Apr 2018 to 30 Jun 2019
Post Partum Hemorrhage
238 more mention it but do not test it. They only measure it or name it in their text.