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Profiles of Drug Substances,... 2022A comprehensive profile of danazol describing the nomenclatures, formulae, elemental composition, appearance, uses and applications is presented. The profile contains...
A comprehensive profile of danazol describing the nomenclatures, formulae, elemental composition, appearance, uses and applications is presented. The profile contains the method which was utilized for the preparation of the drug substance and its respective scheme is outlined. The physical characteristics of the drug including the solubility, X-ray powder diffraction pattern, differential scanning calorimetry, thermal behavior and spectroscopic studies are described. The methods which were used for the analysis of the drug substance in bulk drug and/or in pharmaceutical formulations including the compendial, spectrophotometric, electrochemical and the chromatographic methods are reported. The stability, toxicity, pharmacokinetics, bioavailability, drug evaluation and monitoring, comparisons, pharmacology, in addition to several compiled reviews on the drug substance which were involved. Finally, two hundred and seventy-nine references are listed at the end of this profile.
Topics: Biological Availability; Danazol; Drug Compounding; Drug Stability; Solubility; X-Ray Diffraction
PubMed: 35396014
DOI: 10.1016/bs.podrm.2021.10.005 -
Annals of Internal Medicine May 1982Danazol, approved 5 years ago for the treatment of pelvic endometriosis, has recently been approved for treating cystic disease of the breast. As the mechanisms of... (Review)
Review
Danazol, approved 5 years ago for the treatment of pelvic endometriosis, has recently been approved for treating cystic disease of the breast. As the mechanisms of action of this drug are made clear, the clinical syndromes that can be treated by this impeded androgen have increased dramatically. Results of controlled prospective clinical studies on the drug have increased our understanding of the pathophysiology of several poorly understood diseases. Danazol is well tolerated by most patients; the side effects are mild and reversible.
Topics: Angioedema; Contraceptive Agents; Danazol; Endometriosis; Female; Fibrocystic Breast Disease; Gonadotropins; Gynecomastia; Humans; Lupus Erythematosus, Systemic; Male; Melkersson-Rosenthal Syndrome; Menstruation Disturbances; Pregnadienes; Puberty, Precocious; alpha 1-Antitrypsin Deficiency
PubMed: 7041729
DOI: 10.7326/0003-4819-96-5-625 -
Oncology (Williston Park, N.Y.) Dec 2023Purpose To study the potential utility of danazol for treating patients with myelodysplastic syndromes, with a focus on efficacy and adverse effects (AEs). Methods... (Review)
Review
Purpose To study the potential utility of danazol for treating patients with myelodysplastic syndromes, with a focus on efficacy and adverse effects (AEs). Methods MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus were searched for relevant publications from inception June 1, 1950, until June 28, 2022. The studies were screened by title and abstract, followed by full-text screening. The quality of the included studies was assessed via a prespecified set of questionnaires. Data on the efficacy measures and adverse outcomes were extracted and included in a descriptive summary. Results Nine studies consisting of 246 participants were included in our review. The overall quality of the included studies was fair. The age of the participants ranged from 61 to 78 years. In all 9 studies, more male patients had been enrolled than female patients. Overall, a proportion of patients in all the studies reported a desired major response to a danazol dose of 400 to 800 mg/day. Few studies did not observe any improvement in the platelet count. Elevated liver enzyme levels, weight gain, headache, dermatitis, and weakness were the most common AEs observed. One study reported a fatal intracerebral hemorrhage in 1 participant. Conclusions Danazol has been effective in increasing platelet count and hemoglobin level. Despite a few AEs, danazol is a safe drug for the treatment of patients with myelodysplastic syndromes.
Topics: Aged; Female; Humans; Male; Middle Aged; Danazol; Myelodysplastic Syndromes
PubMed: 38133562
DOI: 10.46883/2023.25921009 -
The American Journal of Medicine Sep 1989Danazol is a synthetic attenuated androgen that can interfere with normal interactions between the pituitary-hypothalamic axis and the gonads. These effects are mediated... (Review)
Review
Danazol is a synthetic attenuated androgen that can interfere with normal interactions between the pituitary-hypothalamic axis and the gonads. These effects are mediated by complex mechanisms, including those in which danazol can compete with natural steroids in binding to androgen receptors or to sex hormone-binding globulin, possibly displacing natural steroids from this protein, and in binding to reactive sites of enzymes required for synthesis of natural steroids, thereby depressing synthesis. Because of danazol's impairment of the pituitary-hypothalamic interactions with gonads, it is an effective therapeutic agent for treatment of endometriosis and cystic disease of the breast. It is effective in the treatment of hereditary angioneurotic edema, but the mechanism of this therapeutic success is unclear. Danazol has been used, without universal success, in the treatment of other gynecologic and certain hematologic disorders.
Topics: Blood Proteins; Danazol; Gonads; Hematologic Diseases; Humans; Hypothalamus; Pituitary Gland
PubMed: 2486535
DOI: No ID Found -
The Cochrane Database of Systematic... 2000The androgen, Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained infertility. Two randomized... (Review)
Review
BACKGROUND
The androgen, Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained infertility. Two randomized trials were subsequently conducted to assess the effectiveness of danazol in this population.
OBJECTIVES
The objective of this review was to assess the effects of danazol on pregnancy rates in women with unexplained subfertility.
SEARCH STRATEGY
The Cochrane Subfertility Review Group specialised register of controlled trials was searched.
SELECTION CRITERIA
Randomised trials of danazol compared with placebo or no treatment in women with unexplained subfertility.
DATA COLLECTION AND ANALYSIS
Data were extracted by two reviewers.
MAIN RESULTS
Two trials involving 68 women were involved. There was no difference found in pregnancy rate between danazol and placebo (odds ratio 2.57, 95% confidence 0.53 to 12.46).
REVIEWER'S CONCLUSIONS
There is not enough evidence to evaluate the effect of danazol on pregnancy rates in women with unexplained subfertility. The need to use contraception during danazol treatment, adverse effects and costs are additional considerations.
Topics: Danazol; Estrogen Antagonists; Female; Humans; Infertility, Female
PubMed: 10796484
DOI: 10.1002/14651858.CD000069 -
The Cochrane Database of Systematic... Jan 2007The synthetic androgen Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained subfertility. Two... (Review)
Review
BACKGROUND
The synthetic androgen Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained subfertility. Two randomised trials were subsequently conducted to assess the effectiveness of danazol in this population.
OBJECTIVES
The objective of this review was to assess the effect of danazol on live birth rate in women with unexplained subfertility.
SEARCH STRATEGY
We searched the Cochrane Menstrual Disorders and Sub-fertility Group's specialised register of trials (searched November , 2006) the Cochrane Register of Controlled Trials (The Cochrane Library, Issue 4, 2006), MEDLINE (1966-November 2006), EMBASE (1980 - November 2006) and reference lists of articles.
SELECTION CRITERIA
Randomised trials of danazol compared with placebo or no treatment in women with unexplained subfertility.
DATA COLLECTION AND ANALYSIS
Data were extracted by two reviewers EH and GT.
MAIN RESULTS
Two trials involving seventy-one women were included. There was no statistically significant difference in the live birth/ ongoing pregnancy rate between danazol and placebo at the end of treatment (OR 1.16, 95% CI 0.0 to 8.29; P=0.36) or at the end of follow-up (OR 2.41; 95% CI 0.59, 9.82; P=0.22). There was no significant difference in clinical pregnancies following treatment (OR 0.14, 95% CI 0.01, 2.26; P=0.17), however there were significantly more clinical pregnancies during the follow-up period in the danazol group compared with the placebo group (OR 3.15, 95%CI 0.98, 10.10; P<0.05). Multiple side effects were reported.
AUTHORS' CONCLUSIONS
Available data demonstrate no evidence of the benefit of danazol for unexplained subfertility. Although there is insufficient evidence to be certain of this, the need for contraception during treatment and the adverse effects and costs of danazol, make its use for this problem unwarranted. The increased pregnancy rate in the long term follow-up data may be attributable to additional therapies and did not influence the live birth/ongoing pregnancy data.
Topics: Danazol; Estrogen Antagonists; Female; Humans; Infertility, Female
PubMed: 17253444
DOI: 10.1002/14651858.CD000069.pub2 -
International Journal of Gynaecology... Sep 1995The potential long-term impact of danazol on coronary risk hinges on its effect on lipoprotein metabolism rather than its influence on total plasma lipids. Danazol may... (Review)
Review
The potential long-term impact of danazol on coronary risk hinges on its effect on lipoprotein metabolism rather than its influence on total plasma lipids. Danazol may exert a regulatory influence on three key processes in lipoprotein metabolism: hepatic lipase activity; low-density lipoprotein receptor function; and lecithin:cholesterol acyl-transferase activity. Danazol decreases plasma fibrinogen and lipoprotein (a) levels, promotes fibrinolysis and causes a rise in plasminogen. Such changes are beneficial as they inhibit the process of thrombosis. Androgenic properties of danazol produce effects of plasma lipids and lipoproteins which oppose estrogen-induced changes. The usual recipients of danazol therapy are premenopausal females, in whom the absolute risk of ischemic heart disease is low. If the drug were shown to increase ischemic heart disease risk, detrimental factors must be weighted against its considerable and proven clinical benefits.
Topics: Coronary Disease; Danazol; Female; Gonadal Steroid Hormones; Humans; Lipoproteins; Male; Risk Factors
PubMed: 8529771
DOI: 10.1016/0020-7292(95)02511-a -
American Journal of Obstetrics and... Oct 1981The options for the medical management of endometriosis have been expanded by the introduction of the synthetic steroid, danazol. The results of large clinical studies... (Review)
Review
The options for the medical management of endometriosis have been expanded by the introduction of the synthetic steroid, danazol. The results of large clinical studies suggest that danazol treatment produces significant improvement in the symptoms, signs, and laparoscopic findings of endometriosis. The original studies of the pharmacology of danazol concluded that danazol was a strong antigonadotrophin with mild androgenic effects and no other hormonal properties. Recent studies which emphasize the molecular pharmacology of danazol suggest that this steroid has direct effects on hypothalamic-pituitary function, multiple classes of steroid receptors, gonadal steroidogenesis, and endogenous steroid metabolism. These studies demonstrate that: (1) danazol prevents the midcycle surge of luteinizing hormone (LH) and follicle-stimulating hormone (FSH); (2) danazol does not significantly suppress basal LH or FSH in gonadally intact human beings; (3) in castrated animals danazol can prevent the compensatory increase in LH and FSH; (4) danazol binds to androgen, progesterone, and glucocorticoid receptors; (5) danazol does not bind to estrogen receptors; (6) danazol binds to sex hormone-binding globulin and corticosteroid-binding globulin; (7) danazol inhibits multiple enzymes of steroidogenesis; (8) danazol increases the metabolic clearance rate of progesterone; and (9) metabolites of danazol are hormonally active. Given the complex pharmacology of danazol it is inappropriate to continue to refer to danazol as a "selective antigonadotrophin."U
Topics: Animals; Binding, Competitive; Cats; Danazol; Endometriosis; Enzyme Inhibitors; Estradiol; Female; Gonadotropins, Pituitary; Humans; Hypothalamo-Hypophyseal System; In Vitro Techniques; Infertility, Female; Male; Metabolic Clearance Rate; Pregnadienes; Progesterone; Pseudopregnancy; Rabbits; Rats; Receptors, Steroid; Thyroid Gland; Uterine Neoplasms
PubMed: 7025640
DOI: 10.1016/0002-9378(81)90611-6 -
Drugs May 1980
Review
Topics: Danazol; Endometriosis; Female; Hormones; Humans; Infertility; Male; Pregnadienes
PubMed: 6993180
DOI: 10.2165/00003495-198019050-00002 -
The Cochrane Database of Systematic... Jul 2007Heavy menstrual bleeding (HMB) is an important cause of ill health in pre menopausal women. Medical therapy, with the avoidance of possibly unnecessary surgery is an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Heavy menstrual bleeding (HMB) is an important cause of ill health in pre menopausal women. Medical therapy, with the avoidance of possibly unnecessary surgery is an attractive treatment option, but there is considerable variation in practice and uncertainty about the most effective therapy. Danazol is a synthetic steroid with anti-oestrogenic and anti progestogenic activity, and weak androgenic properties. Danazol suppresses oestrogen and progesterone receptors in the endometrium, leading to endometrial atrophy (thinning of the lining of the uterus) and reduced menstrual loss and to amenorrhoea in some women.
OBJECTIVES
To determine the effectiveness and tolerability of Danazol when used for heavy menstrual bleeding in women of reproductive years.
SEARCH STRATEGY
We searched the Menstrual Disorders and Subfertility Group's Specialised Register (April 2007). We also searched the Cochrane Controlled Trials Register (Cochrane Library, Issue 2, 2007), MEDLINE (1966 to April 2007), EMBASE (1980 to April 2007, CINAHL (1982 to April 2007). Attempts were also made to identify trials from citation lists of included trials and relevant review articles.
SELECTION CRITERIA
Randomised controlled trials of Danazol versus placebo, any other medical (non-surgical) therapy or Danazol in different dosages for heavy menstrual bleeding in women of reproductive age with regular HMB measured either subjectively or objectively. Trials that included women with post menopausal bleeding, intermenstrual bleeding and pathological causes of heavy menstrual bleeding were excluded.
DATA COLLECTION AND ANALYSIS
Nine RCTs, with 353 women, were identified that fulfilled the inclusion criteria. Quality assessment and data extraction were performed independently by two reviewers. The main outcomes were menstrual blood loss, the number of women experiencing adverse effects, weight gain, withdrawals due to adverse effects and dysmenorrhoea. If data could not be extracted in a form suitable for meta-analysis, they were presented in a descriptive format.
MAIN RESULTS
Most data were not in a form suitable for meta analysis, and the results are based on a small number of trials, all of which are under-powered. Danazol appears to be more effective than placebo, progestogens, NSAIDs and the OCP at reducing MBL, but confidence intervals were wide. Treatment with Danazol caused more adverse events than NSAIDs (OR 7.0; 95% CI 1.7 to 28.2) and progestogens (OR 4.05, 95% CI 1.6 to10.2). Danazol was shown to significantly lower the duration of menses when compared with NSAIDs (WMD -1.0; 95% CI -1.8 to -0.3) and a progesterone releasing IUD (WMD -6.0; 95% CI -7.3 to -4.8). There were no randomised trials comparing Danazol with tranexamic acid or the levonorgestrel-releasing intrauterine system.
AUTHORS' CONCLUSIONS
Danazol appears to be an effective treatment for heavy menstrual bleeding compared to other medical treatments. The use of Danazol may be limited by its side effect profile, its acceptability to women and the need for continuing treatment. The small number of trials, and the small sample sizes of the included trials limit the recommendations for clinical care. Further studies are unlikely in the future and this review will not be updated unless further studies are identified.
Topics: Danazol; Estrogen Antagonists; Female; Humans; Menorrhagia; Randomized Controlled Trials as Topic
PubMed: 17636649
DOI: 10.1002/14651858.CD001017.pub2