Norgestrel And Ethinyl Estradiol

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more

Treatment

7 FDA approvals

20 Active Studies for Norgestrel And Ethinyl Estradiol

What is Norgestrel And Ethinyl Estradiol

Levonorgestrel

The Generic name of this drug

Treatment Summary

Levonorgestrel (LNG) is a synthetic hormone similar to progesterone used in contraception and hormone therapy. It is also known as Plan B and is used as a single agent in emergency contraception, as an IUD (intrauterine device, such as Jaydess, Kyleena, and Mirena), and as a long-term combination contraceptive. Levonorgestrel is the most widely used emergency contraceptive, was approved by the FDA in 1982, and is more effective and has fewer side effects than older emergency contraception regimens.

Triphasil-21

is the brand name

image of different drug pills on a surface

Norgestrel And Ethinyl Estradiol Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Triphasil-21

Levonorgestrel

1984

243

Approved as Treatment by the FDA

Levonorgestrel, also known as Triphasil-21, is approved by the FDA for 7 uses including Osteoporosis, Postmenopausal and Menopause .

Osteoporosis, Postmenopausal

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

Menopause

Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Estradiol

Postmenopausal Osteoporosis

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

moderate Menopausal Vasomotor Symptoms

Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol

Has had at least 1 child

Emergency Contraception

Hot flashes

Used to treat Menopause in combination with Estradiol

Effectiveness

How Norgestrel And Ethinyl Estradiol Affects Patients

Levonorgestrel is used as an emergency contraceptive to prevent pregnancy. It works by interfering with ovulation, fertilization, and implantation. If taken within 72 hours after sex, the pill is 89% effective at preventing pregnancy. Intrauterine and implantable devices are more than 99% effective. Levonorgestrel is also used as part of hormonal therapy to help prevent endometrial cancer caused by unopposed estrogen.

How Norgestrel And Ethinyl Estradiol works in the body

Levonorgestrel works in a few different ways to prevent pregnancy. It prevents ovulation by slowing the release of the hormone that triggers it. It also thickens cervical mucus, making it harder for sperm to reach an egg and survive. Finally, it can make the endometrium less receptive to a fertilized egg, so that implantation doesn't occur. Levonorgestrel is also sometimes used in combination with estrogen to reduce the risk of endometrial cancer.

When to interrupt dosage

The proposed measure of Norgestrel And Ethinyl Estradiol is reliant upon the determined state, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The amount of dosage varies, as per the technique of delivery specified in the table below.

Condition

Dosage

Administration

Osteoporosis, Postmenopausal

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Transdermal, Tablet, film coated - Oral, Tablet, film coated, Implant

Endometrial Hyperplasia

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Transdermal, Tablet, film coated - Oral, Tablet, film coated, Implant

Endometriosis

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Transdermal, Tablet, film coated - Oral, Tablet, film coated, Implant

Hot flashes

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Transdermal, Tablet, film coated - Oral, Tablet, film coated, Implant

Emergency Contraception

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Transdermal, Tablet, film coated - Oral, Tablet, film coated, Implant

Menopause

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Transdermal, Tablet, film coated - Oral, Tablet, film coated, Implant

Menorrhagia

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Transdermal, Tablet, film coated - Oral, Tablet, film coated, Implant

Has had at least 1 child

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Transdermal, Tablet, film coated - Oral, Tablet, film coated, Implant

moderate Menopausal Vasomotor Symptoms

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant - Subcutaneous, Transdermal, Tablet, film coated - Oral, Tablet, film coated, Implant

Warnings

Norgestrel and Ethinyl Estradiol has forty-three contraindications, and it should not be used in combination with the conditions given in the following table.

Norgestrel And Ethinyl Estradiol Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Levonorgestrel may interact with Pulse Frequency

Abortion, Septic

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Abortion, Spontaneous

Do Not Combine

HCG elevated

Do Not Combine

Pelvic Infection

Do Not Combine

Vaginitis

Do Not Combine

Acute Coryza

Do Not Combine

Breast Neoplasms

Do Not Combine

Uterine Cervicitis

Do Not Combine

Communicable Diseases

Do Not Combine

Gonorrhea

Do Not Combine

Breast Cancer

Do Not Combine

Intrauterine Devices

Do Not Combine

Liver Neoplasms

Do Not Combine

congenital or aquired uterine abnormality

Do Not Combine

Chlamydia Infections

Do Not Combine

Hypersensitivity

Do Not Combine

Emergency Contraception

Do Not Combine

Endocarditis, Bacterial

Do Not Combine

Vaginosis, Bacterial

Do Not Combine

suspected pregnancy

Do Not Combine

Uterine Cervicitis

Do Not Combine

Uterine Neoplasms

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Breast Neoplasms

Do Not Combine

Uterine Cervical Neoplasms

Do Not Combine

Fibroid Tumor

Do Not Combine

Endometritis

Do Not Combine

chlamydial cervical infection

Do Not Combine

PAP Test Abnormalities

Do Not Combine

Liver Failure, Acute

Do Not Combine

Uterine anomaly distorting uterine cavity

Do Not Combine

Breast Cancer

Do Not Combine

Cervical Dysplasia

Do Not Combine

Thromboembolism

Do Not Combine

Bacterial Vaginosis

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Breast

Do Not Combine

Vaginal Bleeding

Do Not Combine

Bacterial Vaginosis

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Gonorrhea

Do Not Combine

There are 20 known major drug interactions with Norgestrel And Ethinyl Estradiol.

Common Norgestrel And Ethinyl Estradiol Drug Interactions

Drug Name

Risk Level

Description

Astemizole

Major

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

Axitinib

Major

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

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Levonorgestrel.

Copanlisib

Major

The metabolism of Copanlisib can be decreased when combined with Levonorgestrel.

Crizotinib

Major

The metabolism of Crizotinib can be decreased when combined with Levonorgestrel.

Norgestrel And Ethinyl Estradiol Toxicity & Overdose Risk

The toxic dose of levonorgestrel in rats is higher than 5000mg/kg. Signs of an overdose may include nausea and bleeding. Treatment for an overdose includes symptom relief and contacting a poison control center. There is no known antidote for this drug.

Norgestrel And Ethinyl Estradiol Novel Uses: Which Conditions Have a Clinical Trial Featuring Norgestrel And Ethinyl Estradiol?

99 active clinical trials are being conducted to evaluate the potential of Norgestrel And Ethinyl Estradiol in managing Postmenopausal Osteoporosis, having had at least one child and Endometrial Hyperplasia.

Condition

Clinical Trials

Trial Phases

Endometriosis

27 Actively Recruiting

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

Hot flashes

21 Actively Recruiting

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

Menorrhagia

3 Actively Recruiting

Phase 1, Phase 2, Not Applicable

Has had at least 1 child

0 Actively Recruiting

Endometrial Hyperplasia

3 Actively Recruiting

Not Applicable, Phase 2, Phase 3

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Menopause

0 Actively Recruiting

Osteoporosis, Postmenopausal

0 Actively Recruiting

Emergency Contraception

1 Actively Recruiting

Phase 4

Norgestrel And Ethinyl Estradiol Reviews: What are patients saying about Norgestrel And Ethinyl Estradiol?

5

Patient Review

8/10/2011

Norgestrel And Ethinyl Estradiol for Abnormally Long or Heavy Periods

I experienced some pimples and breakouts after starting this medication, but they cleared up after a month. I'm still left with red spots on my face, however. Additionally, I've been getting headaches that don't go away despite taking ibuprofen. My mood has also been more erratic lately.

3.7

Patient Review

4/18/2010

Norgestrel And Ethinyl Estradiol for Painful Periods

3.7

Patient Review

2/23/2012

Norgestrel And Ethinyl Estradiol for Birth Control

I'm undecided about this birth control.

2.3

Patient Review

2/13/2014

Norgestrel And Ethinyl Estradiol for Endometriosis

I tried this medication and found that it did nothing to help with my pain, but rather caused a number of other problems like heartburn, leg cramps, and exhaustion. I also couldn't sleep at night which led to cramping during the day.

1.7

Patient Review

1/9/2014

Norgestrel And Ethinyl Estradiol for Painful Periods

Since my last review, I've been taking this HRT for three months. I feel like I've "leveled out" now; the first month I felt great, but now I just feel normal. I've been adding soy to my diet while off for 7 days, and that has helped with the dryness. My sex drive is good, sleeping is so-so, and overall I've had good results.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about norgestrel and ethinyl estradiol

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

What are the side effects of ethinyl estradiol?

"If you experience any of the following side effects, tell your doctor or pharmacist promptly: nausea, vomiting, headache, abdominal cramps or bloating, breast tenderness, swelling of the ankles or feet (retaining fluid), or weight change. You may not have regular periods while taking this medication."

Answered by AI

What is norgestrel ethinyl estradiol used for?

"The ferrous fumarate in this medication helps your body absorb the norgestrel and ethinyl estradiol.

This medication is a combination of norgestrel and ethinyl estradiol, which are two hormones that are used in order to prevent pregnancy. This medication also contains ferrous fumarate, which helps your body absorb the norgestrel and ethinyl estradiol. This medication works by stopping a woman's egg from fully developing each month, which prevents pregnancy."

Answered by AI

Is norgestrel an estrogen?

"This medication is a combination of two female hormones, ethinyl estradiol and norgestrel, that are used to prevent ovulation and pregnancy."

Answered by AI

Can norgestrel stop your period?

"If you experience menstrual irregularities while taking NORGESTREL+ETHINYLESTRADIOL, such as spotting, missed periods, or bleeding between menstrual periods, consult your doctor. If the irregularities do not subside, stop takingNORGESTREL+ETHINYLESTRADIOL for dysmenorrhea."

Answered by AI

Clinical Trials for Norgestrel And Ethinyl Estradiol

Image of VA Greater Los Angeles Healthcare System, West Los Angeles, CA in West Los Angeles, United States.

EBQI Strategies for Women's Health

Any Age
All Sexes
West Los Angeles, CA

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

Waitlist Available
Has No Placebo

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Erin P Finley, PhD MPH

Have you considered Norgestrel And Ethinyl Estradiol clinical trials?

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Image of Erevna Innovations Inc. in Montreal, Canada.

Sculptra + Restylane for Post-Menopausal Skin Concerns

40 - 65
Female
Montreal, Canada

The post-menopausal state is marked by a sharp decline in estrogen, leading to significant structural and functional changes in the skin, including collagen loss, dryness, thinning, and reduced elasticity. To address these concerns, aesthetic injectables products such as Sculptra® Aesthetic (poly-L-lactic-acid \[PLLA- SCA\]) and Restylane Skinboosters®\[HASBV\] (small-particle hyaluronic acid - SP-HA) can be used. PLLA-SCA stimulates collagen production via cellular activation (biostimulator), gradually improving dermal structure. HASBV enhances hydration, elasticity, and skin texture when injected under the skin. Considering that hydration and laxity represent the primary aesthetic concerns in this patient population. Targeted treatment with SP-HA (HASBV) to improve hydration and PLLA-SCA to address laxity have been shown to produce significant clinical outcomes by directly addressing these key dermal deficiencies. This approach forms the basis of the current study.

Phase 4
Waitlist Available

Erevna Innovations Inc.

Andreas Nikolis, MD, PhD

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 William J. Hybl Sports Medicine and Performance Center in Colorado Springs, United States.

Moderate Aerobic Exercise for Menstrual Symptoms

18 - 40
Female
Colorado Springs, CO

The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are: Is there a reduction in physical and/or psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives? Is there a difference in physical and/or psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users? Is a moderate aerobic exercise intervention more effective in reducing physical and/or psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives? Participants will: * Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention. * Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly. * Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length. * Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly. * Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles.

Recruiting
Has No Placebo

William J. Hybl Sports Medicine and Performance Center

Image of Alethios, Inc. in San Francisco, United States.

NettleEndo for Endometriosis

22 - 45
Female
San Francisco, CA

The goal of this clinical trial is to learn if a wearable brain stimulation device called NettleEndo can reduce chronic pelvic pain and improve wellbeing in women with endometriosis. The study also aims to assess the safety and usability of the device when used at home over several months. The main questions it aims to answer are: 1. Does at-home transcranial direct current stimulation (tDCS) reduce daily pain intensity in women with endometriosis? 2. Does the device also improve mood and sleep quality? Researchers will compare two groups-one receiving active brain stimulation and one receiving a sham (placebo) stimulation-to see if the active device provides greater improvements in symptoms. Participants will: 1. Use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks 2. Be randomly assigned to receive either real or sham stimulation through the device 3. Complete daily and weekly symptom ratings through a mobile app 4. Be followed for 90 days after completing the intervention to monitor longer-term effects All activities are completed remotely using a smartphone app. Participants can contact the study team with questions at any time. The study is double-blind, meaning neither participants nor the researchers assessing outcomes will know who received active or sham treatment until the end of the trial.

Recruiting
Online Trial

Alethios, Inc.

Nirav Shah, MD, MPH

Samphire Group, Inc.

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