Safyral

Birth Control, Acne Vulgaris, Folate supplementation therapy + 5 more

Treatment

1 FDA approval

19 Active Studies for Safyral

What is Safyral

Ethinylestradiol

The Generic name of this drug

Treatment Summary

Ethinylestradiol is a synthetic form of the female hormone estrogen. It was developed in the 1930s and is more easily absorbed than other forms of estrogen. It is most commonly found in birth control pills and has been approved by the FDA since 1943.

LOESTRIN Fe 1.5/30

is the brand name

Safyral Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

LOESTRIN Fe 1.5/30

Ethinylestradiol

1973

679

Approved as Treatment by the FDA

Ethinylestradiol, also known as LOESTRIN Fe 1.5/30, is approved by the FDA for 1 uses including Birth Control .

Birth Control

Used to treat Contraception in combination with Levonorgestrel

Effectiveness

How Safyral Affects Patients

Ethinylestradiol is a synthetic estrogen used to stop ovulation and prevent the growth of the uterine lining. It is taken once daily and is generally considered to be a safe drug, although it can increase the risk of blood clots. Patients should speak to their doctor about the potential risks.

How Safyral works in the body

Ethinylestradiol is a synthetic form of estrogen. Taking ethinylestradiol can reduce bone density and suppress ovulation. It works by stopping the hormones that help control ovulation, blocking sperm from traveling to the egg, and preventing the endometrium from changing to allow a fertilized egg to implant. It also reduces luteinizing hormone, making the endometrium less vascular, and increases the amount of sex hormone binding globulin.

When to interrupt dosage

The magnitude of Safyral is contingent upon the determined disorder, including Acne Vulgaris, Hormonal Contraception and Folate supplementation therapy. The measure of dosage is delineated in the following table, in accordance with the mode of administration.

Condition

Dosage

Administration

Birth Control

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Transdermal, Patch, extended release, Insert, extended release, Insert, extended release - Vaginal, Vaginal, Ring - Vaginal, Patch, extended release - Transdermal, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Ring, Capsule, Capsule - Oral

Patient desires oral contraception for birth control

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Transdermal, Patch, extended release, Insert, extended release, Insert, extended release - Vaginal, Vaginal, Ring - Vaginal, Patch, extended release - Transdermal, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Ring, Capsule, Capsule - Oral

Hormonal Contraception

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Transdermal, Patch, extended release, Insert, extended release, Insert, extended release - Vaginal, Vaginal, Ring - Vaginal, Patch, extended release - Transdermal, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Ring, Capsule, Capsule - Oral

Menopause

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Transdermal, Patch, extended release, Insert, extended release, Insert, extended release - Vaginal, Vaginal, Ring - Vaginal, Patch, extended release - Transdermal, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Ring, Capsule, Capsule - Oral

Acne Vulgaris

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Transdermal, Patch, extended release, Insert, extended release, Insert, extended release - Vaginal, Vaginal, Ring - Vaginal, Patch, extended release - Transdermal, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Ring, Capsule, Capsule - Oral

Folate supplementation therapy

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Transdermal, Patch, extended release, Insert, extended release, Insert, extended release - Vaginal, Vaginal, Ring - Vaginal, Patch, extended release - Transdermal, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Ring, Capsule, Capsule - Oral

Acne Vulgaris

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Transdermal, Patch, extended release, Insert, extended release, Insert, extended release - Vaginal, Vaginal, Ring - Vaginal, Patch, extended release - Transdermal, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Ring, Capsule, Capsule - Oral

Osteoporosis

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Transdermal, Patch, extended release, Insert, extended release, Insert, extended release - Vaginal, Vaginal, Ring - Vaginal, Patch, extended release - Transdermal, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Ring, Capsule, Capsule - Oral

Warnings

Safyral Contraindications

Condition

Risk Level

Notes

Smoking

Do Not Combine

Metrorrhagia

Do Not Combine

estrogen-sensitive cancer

Do Not Combine

Thrombophlebitis

Do Not Combine

Venous Thrombosis

Do Not Combine

Venous Thrombosis

Do Not Combine

Pulse Frequency

Do Not Combine

Breast

Do Not Combine

Coronary Artery Disease

Do Not Combine

high risk of arterial thrombotic disease

Do Not Combine

Thromboembolism

Do Not Combine

Coronary Disease

Do Not Combine

Hypersensitivity

Do Not Combine

Pulse Frequency

Do Not Combine

Adrenal Insufficiency

Do Not Combine

major surgery with prolonged immobilization

Do Not Combine

Pulse Frequency

Do Not Combine

Hypertension

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Breast Cancer

Do Not Combine

Liver Neoplasms

Do Not Combine

Deep Vein Thrombosis

Do Not Combine

Fibrosis

Do Not Combine

Breast

Do Not Combine

Renal Insufficiency

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Ethinylestradiol may interact with Pulse Frequency

There are 20 known major drug interactions with Safyral.

Common Safyral Drug Interactions

Drug Name

Risk Level

Description

Anastrozole

Major

The therapeutic efficacy of Anastrozole can be decreased when used in combination with Ethinylestradiol.

Astemizole

Major

The metabolism of Astemizole can be decreased when combined with Ethinylestradiol.

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Ethinylestradiol.

Belinostat

Major

The metabolism of Belinostat can be increased when combined with Ethinylestradiol.

Binimetinib

Major

The metabolism of Binimetinib can be increased when combined with Ethinylestradiol.

Safyral Toxicity & Overdose Risk

Women who overdose on birth control pills may experience bleeding, nausea, vomiting, breast tenderness, abdominal pain, drowsiness, and fatigue. Treatment should include monitoring of potassium and sodium levels in the body, as well as signs of metabolic acidosis.

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

38 active investigations are examining the potential of Safyral in providing Folate supplementation therapy, Premenstrual Dysphoric Disorder and Menopausal relief.

Condition

Clinical Trials

Trial Phases

Birth Control

19 Actively Recruiting

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

Hormonal Contraception

0 Actively Recruiting

Folate supplementation therapy

0 Actively Recruiting

Patient desires oral contraception for birth control

0 Actively Recruiting

Osteoporosis

0 Actively Recruiting

Acne Vulgaris

0 Actively Recruiting

Acne Vulgaris

0 Actively Recruiting

Menopause

0 Actively Recruiting

Safyral Reviews: What are patients saying about Safyral?

4.7

Patient Review

1/6/2015

Safyral for Birth Control

I've been taking this treatment for three years and have loved it. I never experienced any of the adverse side effects that others have talked about. However, I am now switching because I have developed nausea, an upset stomach, and heavy periods that start on Thursdays and last until Sunday (previously they started on Tuesdays and were much lighter). I think my body just needs a change. My doctor has put me on cryselle, so we'll see how that goes for me.

4.7

Patient Review

7/13/2014

Safyral for Birth Control

Safryal has been working well for me. My periods are shorter and I don't feel any different than normal. The only downside is that I've gained a few pounds, but it's nothing too drastic.

4.3

Patient Review

3/23/2015

Safyral for Birth Control

I was very happy with this pill while my insurance covered it. My periods became extremely light and only lasted 3 days, which was great. I did experience more headaches and migraines, as well as a lower sex drive. My skin was a bit oilier than usual but no terrible breakouts. I'm really going to miss this one!

4.3

Patient Review

7/28/2015

Safyral for Birth Control

I took this pill for two years and it was overall all right, though it did give me some pretty severe mood swings. My Obgyn doctor switched me to a lower estrogen pill called lo loestrin fe so hopefully my mood swings will end soon.

4

Patient Review

3/15/2015

Safyral for Acne

Within a month of using this pill, my skin cleared up perfectly. However, after five months of use, I started to experience low libido, increased potassium levels, and higher cholesterol in my blood work. As a result, I stopped taking the pill and will be seeing a dermatologist instead.

2.7

Patient Review

5/16/2012

Safyral for Birth Control

I have experienced a lot of bloating and stomach pain with this medication. I've experienced nausea and diarrhea, as well as sore breasts. It is also a very costly medication despite the fact that there is nothing particularly special about it other than having folic acid. I switched to a new medication a month after starting Safyral

2.7

Patient Review

3/13/2013

Safyral for Birth Control

I'm not sure if I want to continue using Safyral. I am on day 14 of my period and per my doctor, this is normal. However, I personally don't feel that it is and this whole experience has been quite overwhelming.

2.3

Patient Review

3/30/2012

Safyral for Birth Control

Unfortunately, since starting this birth control, I have gained weight, felt bloated, and constantly desired sweets. In addition, my sex drive has decreased significantly. Although my periods are now lighter, the other negative effects of this medication are not worth it to me.

2.3

Patient Review

10/6/2013

Safyral for Birth Control

I did not enjoy taking this BC pill. I switched from a low estrogen pill and found that it made me gain weight, be more irritable, and my sex drive was lower .

2

Patient Review

10/15/2013

Safyral for Premenstrual Disorder with a State of Unhappiness

I started Safyral in an attempt to level out my hormone-driven emotions. Unfortunately, this led to me having a period for the entire first pack of pills. In addition, I gained a lot of weight and my sex drive plummeted. Intercourse became uncomfortable and eventually avoided altogether. After three months of use, I stopped taking Safyral because my PMDD had gotten worse.

1.7

Patient Review

4/5/2012

Safyral for Birth Control

I have been getting headaches for 6 days in a row. I am have mood swings and i bleed for 18 days with it. This medicine sucks and its raising my blood pressure up. im done taking it

1

Patient Review

3/30/2015

Safyral for Disease of Ovaries with Cysts

This medication has made me incredibly angry and my mood swings are out of control. Additionally, it's killed my sex drive. I'm really unhappy with how this is going and will be speaking to my doctor tomorrow.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about safyral

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

Is safyral a good birth control?

"Safyral for birth control has an average rating of 6.2 from 59 reviewers."

Answered by AI

What is Yaz called now?

"There are two birth control pills on the market today: Yaz and Loryna. Loryna is a generic version of Yaz. Yaz is a brand-name drug."

Answered by AI

What is safyral generic for?

"The active ingredients in this medication are drospirenone, ethinyl estradiol, and levomefolate calcium. This medication comes in the form of tablets, and each tablet contains 3mg of drospirenone, 30micrograms of ethinyl estradiol, and 0.451mg of levomefolate calcium. There are 21 tablets in a package, or 7 tablets for a seven-day supply."

Answered by AI

What is ethinylestradiol used for?

"Drospirenone; ethinyl estradiol is an oral contraceptive that prevents ovulation and pregnancy. It may also be used to treat acne and premenstrual dysphoric disorder (PMDD). It is a combination of the hormones estrogen and progestin."

Answered by AI

Clinical Trials for Safyral

Image of University of California, San Diego in La Jolla, United States.

Lidocaine for Pain Control in Birth Control

18 - 50
Female
La Jolla, CA

The goal of this research study is to learn more about how different uses of a numbing medication might affect pain levels while getting an IUD placed. The investigators are also studying participants opinions of their clinicians' empathy. The investigators are inviting patients who arrive at their clinic visit seeking an IUD. Usually, at University of California, San Diego (UCSD), for patients who have never delivered a baby, clinicians use a buffered paracervical block for before IUD placement. The purpose of this research study is to investigate whether a "buffered" (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block (numbing medication given on both sides of the cervix) is effective in reducing pain during IUD placement in individuals with prior C-sections, the difference between buffered and unbuffered for nulliparous patients, and whether a medicated gel reduces pain with the paracervical block.

Recruiting
Paid Trial

University of California, San Diego

Sheila K Mody, MD, MPH

Image of EmpoweRx, Inc in Del Mar, United States.

HAPPI Software for Birth Control Access

18+
All Sexes
Del Mar, CA

The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are: 1. Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy? 2. Does the HAPPI software make it easier for patients to access birth control? Researchers will compare pharmacists' implementation and patients' access when using the HAPPI software and when not using the HAPPI software to see if the software improves implementation and access. Participants will include pharmacists and patients. Pharmacists will be asked to provide birth control services as normal while using the HAPPI software. Patients will be asked to receive birth control services from a pharmacist as normal, while using the HAPPI software.

Recruiting
Has No Placebo

EmpoweRx, Inc

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Image of University of Colorado Anschutz Medical Campus in Aurora, United States.

Birth Control Pills and DNA Interaction

18 - 45
Female
Aurora, CO

The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how individual bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. The investigators are also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are: * Do individuals with the CYP3A7\*1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill? * Do individuals with the CYP3A7\*1C variant experience higher rates of breakthrough ovulation while taking a desogestrel/ethinyl estradiol combined oral contraceptive pill? * What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users? Participants will take a specific formulation of combined oral contraceptive pill (desogestrel/ethinyl estradiol) and undergo the following procedures: * Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill * Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill * Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill * A transvaginal ultrasound to measure any ovarian follicles (optional procedure)

Phase 4
Recruiting

University of Colorado Anschutz Medical Campus (+2 Sites)

Aaron M Lazorwitz, MD, PhD

Image of HYPE in Bryan, United States.

Game-Based Learning Intervention for Health Behaviors

9 - 15
All Sexes
Bryan, TX

The study aims to implement Using the Connect (UTC), an innovative, game-based intervention designed to increase protective factors and decrease adolescent pregnancies. This intervention will be implemented in Texas middle schools and community-based organizations. The long-term goal is to promote optimal health in youth and prevent adolescent pregnancy in populations disproportionately impacted by adolescent pregnancy and sexually transmitted infection (STI) rates. The short-term objective is to conduct a robust, multi-site clustered randomized controlled trial to evaluate implementation outcomes and the impact of UTC, a novel theory-based game developed using powerful and effective human-centered design (HCD) strategies, on intention to delay sexual activity.

Waitlist Available
Has No Placebo

HYPE (+2 Sites)

Brittany Rosen, PhD, MEd

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Image of OHSU in Portland, United States.

Progestin Contraceptives for Birth Control Effects

18 - 40
Female
Portland, OR

The purpose of the study is to learn more about menstrual changes in progestin contraception users. The investigators are hoping to find out what changes in the endometrium lead to different bleeding patterns during the first year of progestin contraception use. Participants will choose to receive the contraceptive implant (Etonogestrel implant also called Nexplanon) or the contraceptive injectable (Depo-medroxyprogesterone acetate (DMPA) also called Depo-Provera) for up to 12 months. They will be asked to have 4 endometrial biopsies over the course of the study, as well as blood draws, physical exams, and pregnancy tests. Participants will also use a daily text message or email diary to report bleeding patterns. This study's plan is to comprehensively phenotype bleeding patterns and profile the entire endometrium using single-cell RNA seq data (sCRNAseq).

Phase < 1
Recruiting

OHSU

Alison Edelman, MD

Image of University of Colorado Denver in Aurora, United States.

Etonogestrel Implant for Emergency Birth Control

18 - 40
Female
Aurora, CO

The investigators propose a single site, single arm, open label mechanism of action pharmacodynamic pilot study of etonogestrel implant insertion prior to an luteinizing hormone (LH) surge. The investigators will evaluate ovulation rates via serum levels of reproductive hormones and transvaginal ultrasound findings following placement of an etonogestrel implant once the dominant follicle reaches a size of 15mm or greater, but prior to an LH surge, in persons with prior documented regular cycles and confirmed ovulation. The researchers' hypothesis is that ovulation will be inhibited if the etonogestrel implant is placed prior to an LH surge. Based on data from the Food and Drug Administration label for Nexplanon, etonogestrel rises to levels associated with ovulation suppression within 8 hours of placement. Given this rapid increase, it is therefore plausible to assume that ovulation can be inhibited by the implant if placed prior to an LH surge. This study is novel as there have been no published studies evaluating an etonogestrel implant for this indication. The contribution of this proposed research to the literature is significant because current recommendations from the Center for Disease Control (CDC) regarding timing of etonogestrel implant placement are stringent and not patient-centered. Any day insertion of the etonogestrel implant is supported by retrospective data and this pharmacodynamic data would further support the literature for any day insertion without the need for additional emergency contraception. If results support the investigators' hypothesis, it could increase access to contraception and decrease duplicative therapy.

Phase 4
Recruiting

University of Colorado Denver

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