Lybrel

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more
Treatment
7 FDA approvals
20 Active Studies for Lybrel

What is Lybrel

LevonorgestrelThe Generic name of this drug
Treatment SummaryLevonorgestrel (LNG) is a hormone used for contraception and hormone therapy. It is also known as Plan B, and can be taken as a single dose for emergency contraception, inserted as an intrauterine device (IUD), or implanted as a long-term contraceptive. It was the first emergency contraceptive to contain only progesterone and was approved by the FDA in 1982. It has been demonstrated to be highly effective with few estrogenic side effects. Globally, levonorgestrel is the most commonly used emergency contraceptive.
Triphasil-21is the brand name
image of different drug pills on a surface
Lybrel 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 Postmenopausal Osteoporosis and Osteoporosis, Postmenopausal .
Postmenopausal Osteoporosis
Used to treat Postmenopausal Osteoporosis in combination with Estradiol
Osteoporosis, Postmenopausal
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
Menopause
Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Estradiol
Emergency Contraception
Hot flashes
Used to treat Menopause in combination with Estradiol

Effectiveness

How Lybrel Affects PatientsLevonorgestrel is an emergency contraceptive that can help prevent pregnancy if taken within 72 hours of having unprotected sex. It works by stopping ovulation, fertilization, and implantation. This type of contraceptive is 89% effective when used according to the instructions. Intrauterine and implantable devices that release levonorgestrel are 99% effective in preventing pregnancy. Additionally, levonorgestrel used in hormone therapy can help reduce the risk of endometrial cancer caused by taking estrogen without other hormones.
How Lybrel works in the bodyLevonorgestrel works in several ways to prevent pregnancy. It suppresses the release of hormones that trigger ovulation, making it difficult for an egg to be released from the ovary. It thickens cervical mucus, making it more difficult for sperm to travel through the cervix and fertilize an egg. It can also alter the endometrium, making it harder for a fertilized egg to implant and develop. In hormone therapy, levonorgestrel helps prevent endometrial proliferation, which can lead to cancer when used with estrogen.

When to interrupt dosage

The prescribed dosage of Lybrel is subject to the identified condition, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The magnitude of dosage is contingent on the technique of delivery featured in the table below.
Condition
Dosage
Administration
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, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral
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, Transdermal, Patch - Transdermal, Patch, Insert, extended release, Insert, extended release - Intrauterine, Subcutaneous, Implant, Implant - Subcutaneous, Tablet, film coated, Tablet, film coated - Oral

Warnings

Lybrel has forty-three contraindications, and it should not be amalgamated while enduring any of the conditions in the following table.Lybrel 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 Lybrel.
Common Lybrel 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.
Lybrel Toxicity & Overdose RiskThe least toxic dose of levonorgestrel in rats is greater than 5000mg/kg. Overdosing on this drug can cause nausea and bleeding, for which no specific antidote exists. To treat an overdose, provide symptomatic treatment and contact the local poison control center.
image of a doctor in a lab doing drug, clinical research

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

99 active clinical trials are currently being conducted to evaluate the potential of Lybrel to ameliorate Postmenopausal Osteoporosis, Post-Partum Women and Endometrial Hyperplasia.
Condition
Clinical Trials
Trial Phases
Hot flashes
16 Actively Recruiting
Phase 1, Phase 4, Not Applicable, Early Phase 1, Phase 2
Endometriosis
29 Actively Recruiting
Early Phase 1, Phase 2, Phase 3, Not Applicable, Phase 4
Has had at least 1 child
0 Actively Recruiting
Menorrhagia
0 Actively Recruiting
Endometrial Hyperplasia
4 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

Lybrel Reviews: What are patients saying about Lybrel?

5Patient Review
2/17/2011
Lybrel for Abnormally Long or Heavy Periods
Lybrel has been an amazing addition to my life. I no longer have to deal with heavy periods or the side effects that come with them like anemia. In the 8 months since I've started taking this pill, I haven't had any bleeding or spotting and haven't experienced any negative side effects.
5Patient Review
8/8/2012
Lybrel for Endometriosis
Lybrel has been a game changer for me. I haven't had a period in years, and I used to suffer from debilitating menstrual pain, bloating, and other issues. This pill has helped me avoid all of that and has also not caused weight gain or acne like other birth control pills have.
5Patient Review
10/19/2012
Lybrel for Painful Periods
Lybrel has been a total life-changer for me. Having no period is incredible and makes such a difference in my day-to-day mood and energy levels. I don't know why more people haven't switched to this!
5Patient Review
6/10/2013
Lybrel for Abnormally Long or Heavy Periods
Lybrel has been a life-changer for me. I used to get my period every April, but now I only have it for about three days. I've also lost the weight I gained from Depo and my mood swings are much more manageable. I would highly recommend this pill to anyone who is considering it.
5Patient Review
8/9/2011
Lybrel for Abnormally Long or Heavy Periods
This treatment has been a godsend for me. I'm peri-menopausal and my doctor put me on this instead of having a hysterectomy. I take it daily and have not had a period since starting it.
View All Reviews

Patient Q&A Section about lybrel

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

Why is Lybrel discontinued?

"The decision to stop selling Lybrel was only because of money, not because it was unsafe. Many companies submitted licenses to the FDA to sell generic versions of the drug, so the company that makes Lybrel decided it wasn't worth selling anymore since they would make less money."

Answered by AI

Can you still get Lybrel?

"Lybrel is no longer available for purchase. Amethyst, manufactured by Watson Laboratories, is now the only option. Each pack of Amethyst contains 28 tablets (90 micrograms levonorgestrel/20 microgram Ethinyl estradiol).Jan 10, 2020"

Answered by AI

Does Lybrel stop your period?

"Lybrel can prevent menstruation in 59% of cases, and 20% of users only experience spotting, which does not require sanitary protection."

Answered by AI

Why was Lybrel discontinued?

"The decision to stop selling Lybrel was purely financial, driven by the number of generic brands of levonorgestrel-ethinyl estradiol submitted to the FDA. Lybrel was not taken off the market for safety reasons or recalled by the FDA."

Answered by AI

Is Lybrel available in the US?

"The Lybrel brand name has been discontinued, but there may be generic equivalents available."

Answered by AI

What is Lybrel used for?

"Lybrel is a medication that contains a combination of female hormones that are used as a form of contraception to prevent pregnancy. The brand name for this medication has been discontinued, but generic versions may still be available."

Answered by AI

Clinical Trials for Lybrel

Have you considered Lybrel clinical trials? We made a collection of clinical trials featuring Lybrel, we think they might fit your search criteria.
Have you considered Lybrel clinical trials? We made a collection of clinical trials featuring Lybrel, we think they might fit your search criteria.
Have you considered Lybrel clinical trials? We made a collection of clinical trials featuring Lybrel, we think they might fit your search criteria.