Depot leuprolide acetate versus danazol in the treatment of women with symptomatic endometriosis: a multicenter, double-blind randomized clinical trial. II. Assessment of safety. The Lupron Endometriosis Study Group.

Wheeler JM, Knittle JD, Miller JD

American journal of obstetrics and gynecology1 Jul 1993Cited by 36 (Europe PMC)

PMID8333471DOI10.1016/0002-9378(93)90126-4PepBankPUB-08333471

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialSafety outcome
In women with endometriosis, similarly small numbers stopped leuprolide or danazol because of side effects.
In plain wordsIn women with endometriosis, similarly small numbers stopped leuprolide or danazol because of side effects.
Peptide
Leuprolide
Outcome
Direction not reportedDiscontinuation due to side effects
Study
n = 270
Comparator
Danazol
Outcome group
Adverse events · Whole body
Studied dose
3.75 mg monthly · injectionAs given in this study (human).
Source sentences
Summary
Similarly small numbers of patients dropped out of the two treatment groups because of the side effects encountered.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 270 patients from 22 centers were randomly selected to receive either leuprolide acetate depot (3.75 mg injected monthly) or danazol (800 mg administered orally daily).
Report a problemFND-0833347103
02HumanRandomized controlled trialSafety outcome
In women with endometriosis, leuprolide caused a greater bone density decrease than danazol.
In plain wordsIn women with endometriosis, bone density decreased more with leuprolide than danazol.
Peptide
Leuprolide
Outcome
DecreaseBone density
Study
n = 270
Comparator
Danazol
Outcome group
Bone and joint · Musculoskeletal
Studied dose
3.75 mg monthly · injectionAs given in this study (human).
Source sentences
Summary
Leuprolide depot caused a greater decrease in bone density; preliminary data suggest a return to baseline on cessation of the drug.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 270 patients from 22 centers were randomly selected to receive either leuprolide acetate depot (3.75 mg injected monthly) or danazol (800 mg administered orally daily).
Report a problemFND-0833347104
03HumanNon-randomized trialSafety outcome
In women with endometriosis, most leuprolide recipients reported side effects, mainly related to hypoestrogenism.
In plain wordsIn women with endometriosis, most leuprolide recipients reported side effects, mainly related to low estrogen.
Peptide
Leuprolide
Outcome
Not applicableSide effects
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
3.75 mg monthly · injectionAs given in this study (human).
Source sentences
Summary
Most patients receiving either drug reported side effects, most of which were related to the hypoestrogenism of leuprolide (e.g., vasodilatation) and relative hyperandrogenism of danazol (e.g., weight gain).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 270 patients from 22 centers were randomly selected to receive either leuprolide acetate depot (3.75 mg injected monthly) or danazol (800 mg administered orally daily).
Report a problemFND-0833347101
04HumanNon-randomized trialSafety outcome
In women with endometriosis, leuprolide-related side effects included vasodilatation.
In plain wordsWomen with endometriosis reported vasodilatation with leuprolide.
Peptide
Leuprolide
Outcome
Not applicableVasodilatation
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
3.75 mg monthly · injectionAs given in this study (human).
Source sentences
Summary
Most patients receiving either drug reported side effects, most of which were related to the hypoestrogenism of leuprolide (e.g., vasodilatation) and relative hyperandrogenism of danazol (e.g., weight gain).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 270 patients from 22 centers were randomly selected to receive either leuprolide acetate depot (3.75 mg injected monthly) or danazol (800 mg administered orally daily).
Report a problemFND-0833347102
05HumanNon-randomized trialSafety outcome
In women with endometriosis, preliminary data suggested bone density returned to baseline after leuprolide cessation.
In plain wordsIn women with endometriosis, preliminary data suggested bone density returned to baseline after leuprolide stopped.
Peptide
Leuprolide
Outcome
IncreaseBone density after cessation
Study
n: not reported in source
Comparator
Bone density during treatment
Outcome group
Bone and joint · Musculoskeletal
Studied dose
3.75 mg monthly · injectionAs given in this study (human).
Source sentences
Summary
Leuprolide depot caused a greater decrease in bone density; preliminary data suggest a return to baseline on cessation of the drug.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 270 patients from 22 centers were randomly selected to receive either leuprolide acetate depot (3.75 mg injected monthly) or danazol (800 mg administered orally daily).
Report a problemFND-0833347105

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

PepBank is a research reference. Talk to a doctor before you use any peptide.