Synarel

Endometriosis, Puberty, Precocious

Treatment

4 FDA approvals

20 Active Studies for Synarel

What is Synarel

Nafarelin

The Generic name of this drug

Treatment Summary

Nafarelin is a hormone medication used to treat central precocious puberty and endometriosis. It works by mimicking the natural gonadotropin-releasing hormone in the body and stimulating hormones responsible for sexual development and reproductive function.

Synarel

is the brand name

image of different drug pills on a surface

Synarel Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Synarel

Nafarelin

1990

1

Approved as Treatment by the FDA

Nafarelin, also called Synarel, is approved by the FDA for 4 uses like Central Precocious Puberty (CPP) and Endometriosis .

Central Precocious Puberty (CPP)

Endometriosis

Endometriosis

Puberty, Precocious

Effectiveness

How Synarel Affects Patients

Nafarelin is a drug that works to stimulate the pituitary gland to release hormones, LH and FSH, which in turn lead to a rise in gonadal steroid production. Taking this drug twice a day lead to decreased gonadal steroid levels after about 4 weeks. When the treatment is stopped, normal pituitary and ovarian function is restored, and the levels of estradiol return to the pre-treatment levels. It should be noted that endometriosis may return after stopping any hormonal therapy or surgery that leaves the ovaries and/or uterus intact.

How Synarel works in the body

Nafarelin works by blocking the GnRH receptor and decreasing production of hormones like estrogen and testosterone. This leads to a decrease in secondary sexual characteristics in children, a dramatic decrease in the hormones that cause endometriosis, and the suppression of growth in children. When nafarelin is stopped, hormone levels usually return to what they were before treatment.

When to interrupt dosage

The measure of Synarel is subject to the identified affliction. The amount of dosage is contingent upon the method of administration detailed in the below table.

Condition

Dosage

Administration

Endometriosis

, 2.0 mg/mL, 0.2 mg/pump actuation

Nasal, , Aerosol, metered, Aerosol, metered - Nasal, Liquid, Liquid - Nasal, Spray, metered, Spray, metered - Nasal

Puberty, Precocious

, 2.0 mg/mL, 0.2 mg/pump actuation

Nasal, , Aerosol, metered, Aerosol, metered - Nasal, Liquid, Liquid - Nasal, Spray, metered, Spray, metered - Nasal

Warnings

Synarel has two contra-indications, thus it should not be used in cases of the conditions in the following table.

Synarel Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Vaginal Hemorrhage

Do Not Combine

There are 20 known major drug interactions with Synarel.

Common Synarel Drug Interactions

Drug Name

Risk Level

Description

Capromab pendetide

Major

Nafarelin may decrease effectiveness of Capromab pendetide as a diagnostic agent.

Corifollitropin alfa

Major

The therapeutic efficacy of Corifollitropin alfa can be increased when used in combination with Nafarelin.

Choline C 11

Minor

Nafarelin may decrease effectiveness of Choline C 11 as a diagnostic agent.

Acipimox

Moderate

The risk or severity of myopathy, rhabdomyolysis, and myoglobinuria can be increased when Nafarelin is combined with Acipimox.

Aluminium clofibrate

Moderate

The risk or severity of myopathy, rhabdomyolysis, and myoglobinuria can be increased when Nafarelin is combined with Aluminium clofibrate.

Synarel Toxicity & Overdose Risk

Tests on animals have found no negative effects from administering up to 60 times the recommended human dose of GnRH analogs. So far, no negative effects have been reported from overdosing on this drug.

image of a doctor in a lab doing drug, clinical research

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

30 active studies are presently investigating the potential of Synarel to address Central Precocious Puberty (CPP) symptoms.

Condition

Clinical Trials

Trial Phases

Puberty, Precocious

1 Actively Recruiting

Phase 3

Endometriosis

27 Actively Recruiting

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

Synarel Reviews: What are patients saying about Synarel?

4.3

Patient Review

2/22/2017

Synarel for Endometriosis

This is the only treatment that has given me any relief from my endometriosis. I've been using it for three months now, and it's really helped. However, under the new insurance program, I won't be able to afford it.

3

Patient Review

5/15/2014

Synarel for Endometriosis

This was my doctor's go-to recommendation for endometriosis after two surgeries. It took a little while to start working, but it completely changed my life for the better. I was pain-free for three years – something I hadn't experienced since I was a preteen. Unfortunately, when my original prescribing doctor retired, their replacement refused to let me continue taking it because they said I had been on it for too long (six years). Just a few short years later, I ended up getting a complete hysterectomy. If only I could have stayed on the Synarel!

2.3

Patient Review

2/19/2014

Synarel for Endometriosis

This treatment caused me severe sinus pain, and I developed ringing in my ears after using it for just two weeks. The ringing/fuzzy sound is still happening even after stopping the spray five weeks into the course.I have stopped using it and, two weeks later, I am still having trouble hearing over the noise in my ears. It did start to ease some of my abdominal pains but, overall, this was a very unpleasant experience.

1

Patient Review

5/8/2010

Synarel for Endometriosis

Do not use this medication under any circumstances. It caused me debilitating, long-term depression and I will never be the same.
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Patient Q&A Section about synarel

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

Is Synarel a hormone blocker?

"Nafarelin spray interrupts the creation of regularly occurring female sexual orientations. Your PCP will reveal to you how often to utilize it. You might need to rehash the portion on the off chance that you sneeze promptly in the wake of utilizing the shower."

Answered by AI

What is Synarel used for in IVF?

"A specialist may prescribe Synarel to assist with in-vitro fertilisation (IVF) by decreasing the amount of estrogen produced by the ovaries. This provides more control for subsequent stimulation of the ovaries to produce eggs."

Answered by AI

What does Synarel spray do?

"This medication helps to decrease the amount of abnormal tissue, as well as the symptoms of endometriosis, such as pelvic pain, painful menstrual cramps, and pain during/after sex. This medication is also used by children to treat a certain type of early puberty, known as central precocious puberty, which is caused by an excess of gonadotropins."

Answered by AI

How quickly does Synarel work?

"For that reason, you need to take it as an intranasal spray two to three times a day, starting two to three months before you want your periods to stop.

Reduced oestrogen levels will usually be observed after one month of taking Synarel, in the form of either stopped or reduced periods. Synarel needs to be absorbed into the bloodstream in order to be effective, so it is administered as an intranasal spray two to three times a day, ideally starting two to three months before periods are desired to be stopped."

Answered by AI

Clinical Trials for Synarel

Image of University Hospitals Cleveland Medical Center in Cleveland, United States.

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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Image of Baylor College of Medicine in Hosuton, United States.

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

Image of Boston Children's Hospital in Boston, United States.

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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elleFA App for Endometriosis

18+
Female
Montreal, Canada

Endometriosis is a chronic incurable disease where endometrial-like tissue grows outside of the uterus, and causes symptoms such as debilitating menstrual pain, pain during intercourse, infertility, constipation, and bloating, which hurts their quality of life. Endometriosis is estimated to affect approximately 10% of women. Despite this, there's currently not enough research on this disease; in Canada it takes on average 5.4 years to get a diagnosis (from when symptoms start), and once diagnosed, women often have to go through a trial-and-error process to find a treatment that can manage their symptoms. Misunderstanding symptoms and struggling with patient-provider communication both contribute to these delays in diagnosis and finding the best treatment. Mobile health applications have been a promising new tool to self-track symptoms and treatments. There are several apps currently available on the market for logging chronic pain, menstrual cycles, and fertility. However, no apps exist specifically for endometriosis that look at the whole spectrum of symptoms, including pain, quality of life, and especially ease of patient-provider communication. The elleFA app is a new, personal endometriosis and health tracking app designed to improve patient-physician dialogue through more direct, efficient, and impactful communication, as patients navigate their condition. This single-arm interventional study aims to test the feasibility of implementing the new elleFA app in a clinical setting for 6 months in pre-menopausal women 18 years and older with endometriosis, and the app's impact on patient experience. Participants will download the elleFA app on their smartphone and will be asked to complete two questionnaires through the app every month for 6 months. Participants can choose to also optionally track their daily symptoms, lifestyle, and treatments, through weekly symptom log summaries through the app. The main study finding will be be patient adherence to using the app over a 6 month study period. Other findings will include user-reported satisfaction with the elleFA app, and the impact of elleFA app use on patient experience communicating with their healthcare team.

Recruiting
Has No Placebo

McGill University Health Center

Andrew Zakhari, MD

Image of Main Line Health in Wynnewood, United States.

Relugolix Combination Therapy for Endometriosis

18+
Female
Wynnewood, PA

The goal of this investigator-initiated single-site clinical trial is to compare the overall quality of life of participants taking Relugolix combination therapy (Rel-CT) following excisional surgery for endometriosis to participants that do not take Rel-CT following the same surgery. Rel-CT is an FDA approved form of medical treatment for endometriosis. It is known to work in treating endometriosis pain. However, investigators do not know whether or not there is a benefit to beginning Rel-CT immediately following surgery. This study will test if patients who take Rel-CT after surgery have better quality of life and less chance the endometriosis comes back, requiring additional surgery. The main question it aims to answer is: \- Does taking Rel-CT following excisional surgery for endometriosis result in higher Endometriosis Health Profile 30 (EHP-30) scores, indicating a positive impact on overall health-related quality of life and well-being? Participants will: * Be randomly assigned to one of two treatment groups. One treatment group will take study drug Rel-CT after having excisional surgery, and the other treatment group will just have the surgery alone. * Be asked to complete questionnaires, called the Endometriosis Health Profile 30 (EHP-30) at 4 timepoints. The first time is before surgery, then at follow-up visits at 1 month, 3 months, and 6 months. The survey has 30 questions that ask about pain, control, powerlessness, emotional well-being, social support, and self-image. Researchers will compare the two treatment groups (Rel-CT and non Rel-CT) to see if there is a change in EHP-30 scores.

Phase 3
Recruiting

Main Line Health

Jordan Klebanoff, MD

Pfizer

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