Administration of nasal nafarelin as compared with oral danazol for endometriosis. A multicenter double-blind comparative clinical trial.

Henzl MR, Corson SL, Moghissi K, Buttram VC, Berqvist C, Jacobson J

The New England journal of medicine1 Feb 1988Cited by 226 (Europe PMC)

PMID2963213DOI10.1056/nejm198802253180805PepBankPUB-02963213

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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with endometriosis, laparoscopic score changes did not differ significantly between nafarelin and danazol groups.
In plain wordsIn patients with endometriosis, laparoscopic score changes did not differ significantly between nafarelin and danazol.
Peptide
Nafarelin
Outcome
No significant changeLaparoscopic score versus danazol
Study
n = 213
Comparator
Danazol 800 mg per day
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
400 or 800 micrograms per day · nasal spray · six monthsAs given in this study (human).
Measurements
Mean laparoscopic score before treatment
21.9 points
800 micrograms nafarelin
Mean laparoscopic score after treatment
12.6 points
800 micrograms nafarelin
Mean laparoscopic score before treatment
20.4 points
400 micrograms nafarelin
Mean laparoscopic score after treatment
11.7 points
400 micrograms nafarelin
Mean laparoscopic score before treatment
18.4 points
danazol
Mean laparoscopic score after treatment
10.5 points
danazol
Source sentences
Summary
The mean laparoscopic scores decreased from 21.9 to 12.6 with 800 micrograms of nafarelin, from 20.4 to 11.7 with 400 micrograms of nafarelin, and from 18.4 to 10.5 with danazol (P = 0.0001 within each group; there were no statistically significant differences between the groups).
1 context sentence(design, population, supporting numbers)
Summary · context
To determine the efficacy of such hormonal manipulation in the treatment of endometriosis, we randomly assigned 213 patients with laparoscopically confirmed endometriosis to receive, for six months, either nafarelin by nasal spray (400 or 800 micrograms per day) or oral danazol (800 mg per day).
Report a problemFND-0296321304
02HumanRandomized controlled trialSafety outcome
In patients with endometriosis, a higher percentage of nafarelin users reported hot flashes than danazol users.
In plain wordsIn patients with endometriosis, hot flashes were more frequent with nafarelin than danazol.
Peptide
Nafarelin
Outcome
IncreaseHot flashes
Study
n = 213
Comparator
Danazol
Outcome group
Adverse events · Whole body
Studied dose
400 or 800 micrograms per day · nasal spray · six monthsAs given in this study (human).
Source sentences
Summary
These changes were not observed in nafarelin users, but a higher percentage of them reported hot flashes and decreased libido.
1 context sentence(design, population, supporting numbers)
Summary · context
To determine the efficacy of such hormonal manipulation in the treatment of endometriosis, we randomly assigned 213 patients with laparoscopically confirmed endometriosis to receive, for six months, either nafarelin by nasal spray (400 or 800 micrograms per day) or oral danazol (800 mg per day).
Report a problemFND-0296321308
03HumanRandomized controlled trialSafety outcome
In patients with endometriosis, a higher percentage of nafarelin users reported decreased libido than danazol users.
In plain wordsIn patients with endometriosis, reduced sexual desire was more frequent with nafarelin than danazol.
Peptide
Nafarelin
Outcome
IncreaseDecreased libido
Study
n = 213
Comparator
Danazol
Outcome group
Sexual function · Reproductive and sexual health
Studied dose
400 or 800 micrograms per day · nasal spray · six monthsAs given in this study (human).
Source sentences
Summary
These changes were not observed in nafarelin users, but a higher percentage of them reported hot flashes and decreased libido.
1 context sentence(design, population, supporting numbers)
Summary · context
To determine the efficacy of such hormonal manipulation in the treatment of endometriosis, we randomly assigned 213 patients with laparoscopically confirmed endometriosis to receive, for six months, either nafarelin by nasal spray (400 or 800 micrograms per day) or oral danazol (800 mg per day).
Report a problemFND-0296321309
04HumanRandomized controlled trialEfficacy outcome
In patients trying to become pregnant after endometriosis treatment, pregnancy rates were similar across nafarelin and danazol groups.
In plain wordsAmong patients trying to conceive after treatment, pregnancy rates were similar with nafarelin and danazol.
Peptide
Nafarelin
Outcome
Direction not reportedPregnancy rates
Study
n = 149
Comparator
Danazol
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
400 or 800 micrograms per day · nasal spray · six monthsAs given in this study (human).
Measurements
Patients who became pregnant after treatment
58 patients
patients who tried to become pregnant
Pregnancy rate
39%
patients who tried to become pregnant
Source sentences
Summary
Of the 149 patients who tried to become pregnant, 58 (39 percent) succeeded after the completion of treatment; similar rates of pregnancy applied to the three treatment groups.
1 context sentence(design, population, supporting numbers)
Summary · context
To determine the efficacy of such hormonal manipulation in the treatment of endometriosis, we randomly assigned 213 patients with laparoscopically confirmed endometriosis to receive, for six months, either nafarelin by nasal spray (400 or 800 micrograms per day) or oral danazol (800 mg per day).
Report a problemFND-0296321305
05HumanNon-randomized trialEfficacy outcome
In patients with endometriosis, more than 80 percent in each nafarelin group had reduced laparoscopic disease extent.
In plain wordsIn patients with endometriosis, disease extent decreased in more than 80 percent of each nafarelin group.
Peptide
Nafarelin
Outcome
DecreaseLaparoscopic disease reduction
Study
n: not reported in source
Comparator
Pretreatment
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
400 or 800 micrograms per day · nasal spray · six monthsAs given in this study (human).
Measurements
Patients with reduced extent of disease at laparoscopy
> 80%
each treatment group
Source sentences
Summary
More than 80 percent of the patients in each treatment group had a reduction in the extent of disease as assessed by laparoscopy.
1 context sentence(design, population, supporting numbers)
Summary · context
To determine the efficacy of such hormonal manipulation in the treatment of endometriosis, we randomly assigned 213 patients with laparoscopically confirmed endometriosis to receive, for six months, either nafarelin by nasal spray (400 or 800 micrograms per day) or oral danazol (800 mg per day).
Report a problemFND-0296321301
06HumanNon-randomized trialEfficacy outcome
In patients with endometriosis, laparoscopic scores decreased from 21.9 to 12.6 with nafarelin, with P = 0.0001 within the group.
In plain wordsIn patients with endometriosis, laparoscopic scores decreased from 21.9 to 12.6 with nafarelin.
Peptide
Nafarelin
Outcome
DecreaseLaparoscopic score
Study
n: not reported in source
Comparator
Pretreatment
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
800 micrograms per day · nasal spray · six monthsAs given in this study (human).
Measurements
Mean laparoscopic score before treatment
21.9 points
800 micrograms nafarelin
Mean laparoscopic score after treatment
12.6 points
800 micrograms nafarelin
P value within group
0.0001 P
800 micrograms nafarelin
Source sentences
Summary
The mean laparoscopic scores decreased from 21.9 to 12.6 with 800 micrograms of nafarelin, from 20.4 to 11.7 with 400 micrograms of nafarelin, and from 18.4 to 10.5 with danazol (P = 0.0001 within each group; there were no statistically significant differences between the groups).
1 context sentence(design, population, supporting numbers)
Summary · context
To determine the efficacy of such hormonal manipulation in the treatment of endometriosis, we randomly assigned 213 patients with laparoscopically confirmed endometriosis to receive, for six months, either nafarelin by nasal spray (400 or 800 micrograms per day) or oral danazol (800 mg per day).
Report a problemFND-0296321302
07HumanNon-randomized trialEfficacy outcome
In patients with endometriosis, laparoscopic scores decreased from 20.4 to 11.7 with nafarelin, with P = 0.0001 within the group.
In plain wordsIn patients with endometriosis, laparoscopic scores decreased from 20.4 to 11.7 with nafarelin.
Peptide
Nafarelin
Outcome
DecreaseLaparoscopic score
Study
n: not reported in source
Comparator
Pretreatment
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
400 micrograms per day · nasal spray · six monthsAs given in this study (human).
Measurements
Mean laparoscopic score before treatment
20.4 points
400 micrograms nafarelin
Mean laparoscopic score after treatment
11.7 points
400 micrograms nafarelin
P value within group
0.0001 P
400 micrograms nafarelin
Source sentences
Summary
The mean laparoscopic scores decreased from 21.9 to 12.6 with 800 micrograms of nafarelin, from 20.4 to 11.7 with 400 micrograms of nafarelin, and from 18.4 to 10.5 with danazol (P = 0.0001 within each group; there were no statistically significant differences between the groups).
1 context sentence(design, population, supporting numbers)
Summary · context
To determine the efficacy of such hormonal manipulation in the treatment of endometriosis, we randomly assigned 213 patients with laparoscopically confirmed endometriosis to receive, for six months, either nafarelin by nasal spray (400 or 800 micrograms per day) or oral danazol (800 mg per day).
Report a problemFND-0296321303
08HumanNon-randomized trialEfficacy outcome
In patients with endometriosis, nafarelin users did not show the HDL decrease seen with danazol.
In plain wordsIn patients with endometriosis, nafarelin users did not show the HDL decrease seen with danazol.
Peptide
Nafarelin
Outcome
No significant changeHDL cholesterol
Study
n: not reported in source
Comparator
Pretreatment
Outcome group
Lipids · Metabolic and weight
Studied dose
400 or 800 micrograms per day · nasal spray · six monthsAs given in this study (human).
Source sentences
Summary
These changes were not observed in nafarelin users, but a higher percentage of them reported hot flashes and decreased libido.
2 context sentences(design, population, supporting numbers)
Summary · context
Danazol use decreased high-density lipoprotein levels and increased low-density lipoprotein levels.
Summary · context
To determine the efficacy of such hormonal manipulation in the treatment of endometriosis, we randomly assigned 213 patients with laparoscopically confirmed endometriosis to receive, for six months, either nafarelin by nasal spray (400 or 800 micrograms per day) or oral danazol (800 mg per day).
Report a problemFND-0296321306
09HumanNon-randomized trialEfficacy outcome
In patients with endometriosis, nafarelin users did not show the LDL increase seen with danazol.
In plain wordsIn patients with endometriosis, nafarelin users did not show the LDL increase seen with danazol.
Peptide
Nafarelin
Outcome
No significant changeLDL cholesterol
Study
n: not reported in source
Comparator
Pretreatment
Outcome group
Lipids · Metabolic and weight
Studied dose
400 or 800 micrograms per day · nasal spray · six monthsAs given in this study (human).
Source sentences
Summary
These changes were not observed in nafarelin users, but a higher percentage of them reported hot flashes and decreased libido.
2 context sentences(design, population, supporting numbers)
Summary · context
Danazol use decreased high-density lipoprotein levels and increased low-density lipoprotein levels.
Summary · context
To determine the efficacy of such hormonal manipulation in the treatment of endometriosis, we randomly assigned 213 patients with laparoscopically confirmed endometriosis to receive, for six months, either nafarelin by nasal spray (400 or 800 micrograms per day) or oral danazol (800 mg per day).
Report a problemFND-0296321307

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, 16:36 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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