Danazol

Endometriosis, Thrombocytopenia, Breast + 1 more

Treatment

6 FDA approvals

20 Active Studies for Danazol

What is Danazol

Danazol

The Generic name of this drug

Treatment Summary

Danazol is a man-made steroid that suppresses the hormones released from the pituitary gland. It has some androgenic properties and is used to treat endometriosis and certain types of breast conditions. Danazol works by inhibiting the release of gonadotropins, which are hormones responsible for regulating reproductive functions.

Danocrine

is the brand name

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Danazol Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Danocrine

Danazol

1976

22

Approved as Treatment by the FDA

Danazol, also known as Danocrine, is approved by the FDA for 6 uses which include Endometriosis and Fibrocystic Disease of Breast .

Endometriosis

Fibrocystic Disease of Breast

Hereditary Angioedema (HAE)

Helps manage Hereditary Angioedema (HAE)

Angioedemas, Hereditary

Helps manage Hereditary Angioedema (HAE)

Breast

Endometriosis

Effectiveness

How Danazol Affects Patients

Danazol is a synthetic steroid derived from testosterone. It was the first drug approved by the FDA to specifically treat endometriosis, but is now largely replaced by GnRH agonists. Danazol works by stopping the pituitary gland from producing gonadotropins, and has some androgenic properties.

How Danazol works in the body

Danazol works to suppress the activity of hormones related to the pituitary-ovarian axis. It also limits the production of estrogens in the ovaries, and binds to hormone receptors. In the treatment of endometriosis, it causes normal and ectopic endometrial tissues to become inactive and atrophic. For fibrocystic breast disease, the effect is thought to be related to suppressed estrogenic stimulation. Lastly, it increases the level of a key protein in hereditary angioedema, C1 esterase inhibitor, which helps to control the C4 component of the complement system.

When to interrupt dosage

The suggested measure of Danazol is dependent on the determined condition, such as Thrombocytopenia, Endometriosis and Angioedemas, Hereditary. The amount of dosage changes, as per the procedure of delivery (e.g. Capsule or Oral) indicated in the following table.

Condition

Dosage

Administration

Endometriosis

, 100.0 mg, 200.0 mg, 50.0 mg

, Oral, Capsule, Capsule - Oral

Thrombocytopenia

, 100.0 mg, 200.0 mg, 50.0 mg

, Oral, Capsule, Capsule - Oral

Breast

, 100.0 mg, 200.0 mg, 50.0 mg

, Oral, Capsule, Capsule - Oral

Angioedemas, Hereditary

, 100.0 mg, 200.0 mg, 50.0 mg

, Oral, Capsule, Capsule - Oral

Warnings

Danazol Contraindications

Condition

Risk Level

Notes

androgen-dependent tumor

Do Not Combine

Thrombosis

Do Not Combine

potential for pregnancy

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Kidney

Do Not Combine

Thromboembolism

Do Not Combine

Porphyrias

Do Not Combine

There are 20 known major drug interactions with Danazol.

Common Danazol Drug Interactions

Drug Name

Risk Level

Description

(R)-warfarin

Major

The metabolism of (R)-warfarin can be decreased when combined with Danazol.

(S)-Warfarin

Major

The metabolism of (S)-Warfarin can be decreased when combined with Danazol.

1,2-Benzodiazepine

Major

The metabolism of 1,2-Benzodiazepine can be decreased when combined with Danazol.

3,5-diiodothyropropionic acid

Major

The metabolism of 3,5-diiodothyropropionic acid can be decreased when combined with Danazol.

5-androstenedione

Major

The metabolism of 5-androstenedione can be decreased when combined with Danazol.

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Danazol Novel Uses: Which Conditions Have a Clinical Trial Featuring Danazol?

43 active clinical trials are currently being conducted to analyze the potential of Danazol in managing Thrombocytopenia, Endometriosis and Breast Symptoms.

Condition

Clinical Trials

Trial Phases

Endometriosis

27 Actively Recruiting

Early Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4

Breast

0 Actively Recruiting

Thrombocytopenia

0 Actively Recruiting

Angioedemas, Hereditary

12 Actively Recruiting

Phase 3, Phase 1, Phase 2, Phase 4

Danazol Reviews: What are patients saying about Danazol?

5

Patient Review

9/11/2009

Danazol for Cystic Disease of the Breast

I felt drowsy, moody, and unbalanced after taking this medication. I also felt a bit heaty and had headaches. The worst part was that I gained weight easily, even while dieting.

5

Patient Review

12/13/2009

Danazol for Prevention of Angioedema Attacks in Patient with Hereditary Angioedema

I've been on Danazol for 28 years and it's definitely been worth the side effects. I'm pain- and swelling-free, thanks to this medication.

5

Patient Review

12/22/2009

Danazol for Prevention of Angioedema Attacks in Patient with Hereditary Angioedema

I've used this drug for 15 years to great effect; it's really helped me control my migraines.

4.7

Patient Review

6/23/2009

Danazol for Prevention of Angioedema Attacks in Patient with Hereditary Angioedema

4.3

Patient Review

10/22/2010

Danazol for Prevention of Angioedema Attacks in Patient with Hereditary Angioedema

I've been on this medication for two years now. My dosage has increased to 100mg twice daily, and I no longer experience any breast pain. The only side effects I've noticed are slight weight gain and flushing, but nothing too severe.

3.7

Patient Review

1/4/2010

Danazol for Cystic Disease of the Breast

I'm currently taking this medication for ITP and, while it has kept my platelets up, I am concerned about potential side effects.

3.7

Patient Review

12/15/2011

Danazol for Endometriosis

I experienced liver problems after using this treatment, so be sure to speak with your doctor before taking it.

3.3

Patient Review

12/18/2010

Danazol for Endometriosis

I've been taking Danazol for 10 years now due to hereditary angioedema. Without it, I end up in the hospital. There are times when I can't afford the medication, and I wish there was some sort of assistance available for people in my situation.

2.7

Patient Review

2/10/2009

Danazol for Endometriosis

1.7

Patient Review

4/8/2013

Danazol for Abnormally Long or Heavy Periods

I started taking this medication six months ago at the dosage of 200mg per day. Almost immediately, I experienced adverse effects such as extreme swelling in my feet and ankles, joint and muscle pain, headaches and migraines. My blood pressure also spiked suddenly and severely, resulting in dizziness; I had to discontinue use immediately. Additionally, my menstrual bleeding stopped after three months but then returned during the fourth month. In short, this medication not only failed to work as intended but also caused a host of unpleasant side effects.

1.7

Patient Review

3/5/2013

Danazol for Prevention of Angioedema Attacks in Patient with Hereditary Angioedema

I had a large cyst removed before starting this treatment, which seemed to go well. However, when I started taking danazol I felt awful. Headaches and vomiting were common for me, but thankfully they subsided after a little while. Even after six months of treatment, I was still bleeding daily. My doctor has since put me on Divigel and scheduled an ultrasound.

1

Patient Review

5/21/2014

Danazol for Endometriosis

Unfortunately, this treatment did nothing to help my endometriosis. If anything, it made the symptoms worse. I would not recommend it to anyone.
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Patient Q&A Section about danazol

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of steroid is danazol?

"Danocrine is a synthetic steroid that causes multiple, diverse biological effects by binding to different types of steroid transport proteins. These include proteins in the circulation as well as specific receptors in target tissues. Danazol also inhibits gonadotropins in the central nervous system, which suppresses gametogenesis and steroidogenesis."

Answered by AI

What is danazol used for in males?

"The present invention involves the use of danazol in the manufacture of a medicament for the treatment of hypogonadism in males. The medicament may be used to treat hypogonadism resulting from any biological or physical cause."

Answered by AI

What are side effects of danazol?

"The following side effects may occur: weight gain, acne, flushing, sweating, voice changes (hoarseness, change in pitch), abnormal growth of body hair (in women), vaginal dryness/irritation, or decreased breast size. If you experience any of these side effects, tell your doctor or pharmacist."

Answered by AI

What is the mechanism of action of danazol?

"Danazol suppresses the pituitary gland's output of gonadotropins, which in turn inhibits fertility. It also has some androgenic properties, meaning it can promote the development of male sex characteristics. Danazol is converted into ethisterone and 17-hydroxymethylethisterone by the liver."

Answered by AI

Clinical Trials for Danazol

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Ketamine for Pelvic Pain

18 - 89
Female
Cleveland, OH

The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA. Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.

Phase 4
Waitlist Available

University Hospitals Cleveland Medical Center

Morgan Cheeks, MD

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Dronabinol for Endometriosis

18 - 64
Female
Hosuton, TX

This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for e endometriosis-associated chronic pelvic pain (endo-CPP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.

Phase 2
Waitlist Available

Baylor College of Medicine (+1 Sites)

Christopher Verrico, PhD in Pharmacology

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Metformin for Endometriosis

15 - 35
Female
Boston, MA

The goal of this pilot trial is to learn if a novel non-hormonal treatment, metformin hydrochloride, works to treat pelvic pain in young women with endometriosis. The main questions it aims to answer are: * Is metformin superior to placebo in alleviating pain symptoms in young women with endometriosis? * Does metformin alter systemic inflammatory markers over 6 months in young women with endometriosis? Researchers will compare metformin to a placebo (a look-alike substance that contains no drug) to see if metformin works to treat pelvic pain. Participants will: * Take drug metformin or a placebo every day for 6 months * Visit the clinic three times: once at baseline (pre-treatment), once at 3 months, and once at 6 months * Keep a daily symptom diary to track pain, bleeding, and usage of any pain medications

Phase 2
Recruiting

Boston Children's Hospital

Jessica Shim, MD

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Peer Empowered Endometriosis Pain Support for Endometriosis

18 - 48
Female
Saint Louis, MO

The goal of this clinical trial is to determine if Peer Empowered Endometriosis Pain Support (PEEPS), an 8-week interdisciplinary, integrative group care program, decreases pain interference in participants with endometriosis-associated chronic pelvic pain between the ages 18 and 48. The main question we aim to answer is: Is PEEPS more effective than Education in decreasing pain interference? Researchers will compare people receiving PEEPS plus usual care to those receiving Education plus usual care to see if people participating in PEEPS demonstrate improvements in pain, physical function, and quality of life. Participants will: * Complete baseline quality of life surveys * Participate in an 8-session group care program * Provide feedback on each session and the program globally * Complete follow up quality of life surveys at PEEPS completion, 6- and 12-months post-completion. * A sub-set will complete semi-structured interviews or focus groups about the experience of participating in PEEPS

Recruiting
Has No Placebo

WashU Medicine (+1 Sites)

Whitney Ross, MD

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