Ortho Evra

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

Treatment

1 FDA approval

19 Active Studies for Ortho Evra

What is Ortho Evra

Ethinylestradiol

The Generic name of this drug

Treatment Summary

Ethinylestradiol is a synthetic form of the hormone estrogen. It was created in 1938 and is used in birth control pills. It has a higher rate of absorption in the body than other forms of estrogen, making it more effective. Ethinylestradiol was officially approved by the FDA in 1943.

LOESTRIN Fe 1.5/30

is the brand name

image of different drug pills on a surface

Ortho Evra 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 Ortho Evra Affects Patients

Ethinylestradiol is a type of synthetic estrogen that helps stop the body from releasing hormones that can lead to ovulation and thickening of the womb lining. It stays in the body for a long time after taking it, and it is generally safe even at higher doses. However, patients should be warned that this drug can increase the risk of blood clots.

How Ortho Evra works in the body

Ethinylestradiol is a synthetic form of estrogen that has several effects on the body. It can reduce bone density, suppress ovulation, and thicken cervical mucus to prevent pregnancy. It also decreases luteinizing hormone and increases sex hormone binding globulin. These changes work together to prevent pregnancy.

When to interrupt dosage

The proposed measure of Ortho Evra is subject to the diagnosed condition, such as Acne Vulgaris, Hormonal Contraception and Folate supplementation therapy. The amount of dosage changes in accordance with the administration technique depicted in the table beneath.

Condition

Dosage

Administration

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

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

Warnings

Ortho Evra has twenty-six contraindications and should not be taken alongside the conditions delineated in the following table.

Ortho Evra 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 Ortho Evra.

Common Ortho Evra 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.

Ortho Evra Toxicity & Overdose Risk

Women who overdose on Yaz may experience bleeding, nausea, vomiting, chest pain, abdominal discomfort, drowsiness, and fatigue. Treatment should include monitoring potassium, sodium, and signs of acidosis, and providing supportive care.

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

Ortho Evra Novel Uses: Which Conditions Have a Clinical Trial Featuring Ortho Evra?

38 active trials are examining the potential of Ortho Evra in providing Folate supplementation therapy, alleviating Premenstrual Dysphoric Disorder symptoms and managing Menopausal symptoms.

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

Ortho Evra Reviews: What are patients saying about Ortho Evra?

4.7

Patient Review

3/19/2014

Ortho Evra for Birth Control

I've only been using Ortho Evra for two weeks, so I may update this later. So far, I much prefer it to the shot because there are no needles and I haven't experienced any negative mood swings. The patch has boosted my sex drive, which is amazing. The only downside is that my breasts have been sore and enlarged, but hopefully that will go away soon.

4.7

Patient Review

6/7/2020

Ortho Evra for Birth Control

Protected me from pregnancy with no effects near as bad as the pill. Only side effect is dramatic changes in my sec drive: extremely high for a month or so to extremely low. I also got bigger breasts. Half a cup size To a cup size bigger. For first three months I was slightly more sensitive emotionally than I was without it - however it was very mild and I got used to it very quickly. Overall much better for my mental health, and my bad stomach than the pill was

4.7

Patient Review

9/26/2016

Ortho Evra for Birth Control

I got nauseous from the pill, but the patch was okay. I spotted at the end of week two for a few days, and my period was lighter. Alcohol swabbing the area (upper thigh for me) letting it dry and applying straight after helped keep the patch on. My skin did react so I change thighs and areas each week, but it always went back to normal after a few days.

4

Patient Review

9/23/2014

Ortho Evra for Birth Control

It's important to remember that everyone experiences things differently. For me, I had severe nausea from the patch. Additionally, after four months I started getting cystic acne; my face was covered in it. However, there were some benefits: a dramatic increase in breast size (almost two cups!) and more energy overall.

3.7

Patient Review

5/19/2014

Ortho Evra for Birth Control

The first two months were tough going. I had nausea and my breasts were bloated and swollen.

2.7

Patient Review

4/21/2014

Ortho Evra for Birth Control

I had a really tough time when I was on this patch. Lots of unpleasant symptoms like headaches, nausea, diarrhea, and lightheadedness. Sometimes I felt so bad that I thought something serious must be wrong with me. Thankfully, it was just the patch!

2.3

Patient Review

8/13/2013

Ortho Evra for Birth Control

The Orth Evra Patch was not effective for me; in fact, I got pregnant twice while using it.

2.3

Patient Review

3/31/2019

Ortho Evra for Birth Control

I used this treatment for three years and generally liked it. It was easy to use with few side effects, mostly just breast soreness. However, my third year on the patch I started having two month long periods with terrible cramping that Ibuprofen couldn't even touch. If it weren't for those issues, I would still be using this product.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about ortho evra

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

What is the generic name for Ortho Evra?

"The generic version of Ortho Evra® will be marketed under the name Zafemy™."

Answered by AI

What is Ortho Evra used for?

"This patch contains a combination of hormone medication and is used to prevent pregnancy. It contains 2 hormones: a progestin (norelgestromin) and an estrogen (ethinyl estradiol). This medication will not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia)."

Answered by AI

Is Ortho Evra still available?

"Ortho Evra is no longer available in the U.S., after the FDA approved Xulane, a generic hormonal birth control patch, in 2014. Xulane provides the same high levels of estrogen that Ortho Evra did. Like Ortho Evra, Xulane has a boxed warning on its label about potential side effects."

Answered by AI

Is Xulane the same as Ortho Evra?

"If you're familiar with the brand Ortho Evra, you'll know that Xulane contains the same active ingredients. Xulane is the generic version of Ortho Evra, which was discontinued in the United States in 2014. Now, Twirla is one of the primary options available."

Answered by AI

Clinical Trials for Ortho Evra

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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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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