Introvale

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

What is Introvale

LevonorgestrelThe Generic name of this drug
Treatment SummaryLevonorgestrel (LNG), also known as Plan B, is a hormone used in contraception and hormone therapy. It can come in a single dose, an intrauterine device, or a subdermal implant. Levonorgestrel is the most widely used emergency contraceptive, and was approved by the FDA in 1982. It has been found to be highly effective with few estrogenic side effects compared to other emergency contraceptives.
Triphasil-21is the brand name
Introvale 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 6 uses including Postmenopausal Osteoporosis and Menopause .
Postmenopausal Osteoporosis
Used to treat Postmenopausal Osteoporosis in combination with Estradiol
Menopause
Used to treat severe Vasomotor Symptoms Associated With Menopause 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 Introvale Affects PatientsLevonorgestrel is a type of contraceptive that works by preventing ovulation, fertilization, and implantation. As an emergency contraceptive pill it can prevent pregnancy up to 72 hours after intercourse, and its effectiveness is 89%. When used in intrauterine or implantable devices, levonorgestrel is more than 99% successful in preventing pregnancy. It can also be used as part of a hormonal therapy to reduce the risk of endometrial cancer caused by estrogen.
How Introvale works in the bodyLevonorgestrel has multiple mechanisms of action. It suppresses ovulation by slowing the release of hormones from the hypothalamus that would normally cause the release of an egg. It also makes the cervical mucus thicker and harder for sperm to pass through, reducing the risk of fertilization. Finally, it can act as an anti-estrogen to reduce the risk of endometrial cancer in those taking estrogen-based hormone therapy.

When to interrupt dosage

The measurement of Introvale is based upon the determined illness, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The amount of dosage is contingent upon the technique of delivery outlined in the table below.
Condition
Dosage
Administration
Hypermenorrhea
, 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
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
Postmenopausal Osteoporosis
, 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
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
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

Introvale has forty-three contraindications, and its utilization should be avoided if any of the conditions in the subsequent table are present.Introvale Contraindications
Condition
Risk Level
Notes
Septic Abortion
Do Not Combine
undiagnosed abnormal genital bleeding
Do Not Combine
infected abortions
Do Not Combine
HCG elevated
Do Not Combine
Pelvic Infection
Do Not Combine
Vaginitis
Do Not Combine
Acute Coryza
Do Not Combine
presence or history of breast cancer
Do Not Combine
Uterine Cervicitis
Do Not Combine
Communicable Diseases
Do Not Combine
gonococcal cervical infection
Do Not Combine
Breast Cancer
Do Not Combine
Intrauterine Devices
Do Not Combine
Neoplasms, Hepatic
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
Bacterial Endocarditis
Do Not Combine
lower genital tract infection
Do Not Combine
suspected pregnancy
Do Not Combine
Uterine Cervicitis
Do Not Combine
uterine neoplasia
Do Not Combine
Pelvic Inflammatory Disease
Do Not Combine
history of progestogen-sensitive breast cancer
Do Not Combine
Cervical Neoplasia
Do Not Combine
Fibroid Tumor
Do Not Combine
Postpartum Endometritis
Do Not Combine
chlamydial cervical infection
Do Not Combine
PAP Test Abnormalities
Do Not Combine
acute liver disease
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
history of 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
gonococcal cervical infection
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Levonorgestrel may interact with Pulse Frequency
There are 20 known major drug interactions with Introvale.
Common Introvale 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.
Introvale Toxicity & Overdose RiskThe lowest toxic dose of levonorgestrel in rats has been found to be greater than 5000mg/kg. Overdosing on this drug may cause nausea and bleeding. People who overdose on levonorgestrel should receive supportive care and contact a local poison control center. There is no specific antidote for levonorgestrel overdose.
image of a doctor in a lab doing drug, clinical research

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

99 active studies are in progress to evaluate the potential of Introvale for treating Postmenopausal Osteoporosis, Women who have had at least one child and Endometrial Hyperplasia.
Condition
Clinical Trials
Trial Phases
Endometriosis
32 Actively Recruiting
Phase 3, Not Applicable, Early Phase 1, Phase 2, Phase 4, Phase 1
Menopause
0 Actively Recruiting
Hot flashes
22 Actively Recruiting
Phase 2, Not Applicable, Phase 1, Phase 4, Early Phase 1
Has had at least 1 child
0 Actively Recruiting
Emergency Contraception
1 Actively Recruiting
Phase 4
Endometrial Hyperplasia
9 Actively Recruiting
Phase 2, Not Applicable
Hypermenorrhea
0 Actively Recruiting
Postmenopausal Osteoporosis
3 Actively Recruiting
Not Applicable, Phase 4
moderate Menopausal Vasomotor Symptoms
0 Actively Recruiting

Introvale Reviews: What are patients saying about Introvale?

5Patient Review
11/14/2015
Introvale for Abnormally Long or Heavy Periods
I've had great results with this birth control. I highly recommend it to other women who are struggling with bad menstrual cycles.
5Patient Review
7/12/2017
Introvale for Birth Control
I've been taking this pill for over seven years and it's really changed my life. I used to have terrible breakouts, but they cleared up within a few weeks of starting this medication. Additionally, my periods are much lighter and less painful than they used to be, and I only get them every three months now.
4.7Patient Review
10/11/2015
Introvale for Abnormally Long or Heavy Periods
I've been using Introvale for about four months now, and it's greatly improved my quality of life. I have light to medium spotting for only four days out of the month, as opposed to an entire week. The cramps are still there unfortunately, but they're manageable.
4.3Patient Review
5/4/2015
Introvale for Abnormally Long or Heavy Periods
This birth control has been a game-changer for me. I used to have my periods every two weeks, and they would last for 11 days! But since starting this prescription, everything has cleared up and I haven't had any problems. There were a few rough patches in the beginning where I felt nauseous and spotted a bit, but things evened out quickly and I've been feeling great ever since.
3.7Patient Review
7/11/2016
Introvale for Abnormally Long or Heavy Periods
I was on this for three months and saw a significant increase in my appetite. I put on 10lbs as a result. Thankfully, I went back to Quasense which curbed my hunger much more effectively.
3.7Patient Review
8/9/2016
Introvale for Birth Control
I've been bleeding more and for longer since I switched to this pill. I'm not a fan, and would prefer to go back to the other birth control pills I was taking before.
3.7Patient Review
5/20/2016
Introvale for Birth Control
I started this pill about a month and a half ago, and just recently started experiencing the worst cramps I've had since I got my period at 13. I was previously on Quasense but when I called in for a refill, my doctor switched me to this pill. I never had any problems with Quasense. Additionally, I've been trying to lose weight for the past few months without any success; in fact, I haven't even lost a pound. Needless to say, I'll be calling my doctor to switch back to Quasense.
3.3Patient Review
10/8/2013
Introvale for Birth Control
I was on Quasense for many years- everything was great, last month the pharmacy switched my generic (thanks Obama). I have been having mood swings,(stress, depression, anger) nausea, fibrocystic tissue pain, cramping. What is the deal? How could it make you feel so bad? I talked to my doctor and she said that there's a chance my body just needs to adjust to the new medication.
3.3Patient Review
4/24/2016
Introvale for Birth Control
I was on Quasense for 6 years, and was switched because I didn't have insurance. This pill is terrible in comparison; I've been spotting and lightly bleeding non-stop for the past two months, plus my period came a month early. The cramps are worse than ever and I constantly feel gassy and dizzy.
3.3Patient Review
3/22/2017
Introvale for Painful Periods
I've been taking this for two months now. The first month went great—no period and only light cramping around the time when my period would have started. But then, halfway through the second month, I started spotting for six days before having a full-blown period with really dark blood. So far, day nine of my period, and I'm hoping it will end soon!
3Patient Review
9/17/2013
Introvale for Birth Control
I was on Jolessa for several years and it worked great, but I was switched to this by the pharmacy and I've been struggling ever since. I'm incredibly depressed and have even had thoughts of suicide. This medication has also made it difficult to handle work/home/school stressors. However, I haven't experienced any issues with bleeding or cramping or weight gain.
3Patient Review
11/19/2019
Introvale for Birth Control
I used Quasense for years. My 4th month using Introvale, I had a stroke.
2.7Patient Review
3/25/2017
Introvale for Abnormally Long or Heavy Periods
I just completed the second month of this three-month package, and I have to say I'm disappointed. The first month was great, but the second month I started spotting randomly, and now for the last two weeks of the pack I've had my period nonstop.
2.7Patient Review
2/19/2018
Introvale for Acne
I experienced some initial success with this treatment, but then started noticing breakouts in new areas of my face. I'm not sure if the two are related, but I'm switching back to my old birth control pill just in case.
2.3Patient Review
6/14/2020
Introvale for Birth Control
I'm disappointed with this medication. I've been bleeding constantly since starting it over three weeks ago. The whole point of taking this pill was to reduce the frequency of my periods, not make them daily occurrences.
2Patient Review
4/1/2019
Introvale for Birth Control
I started this birth control pill after having issues with other brands and excessive bleeding. The day after I took my first pill, I got around 15-20 huge cystic pimples all over my face-- the worst acne breakout of my life. Over a month has passed and nothing has changed with my skin; if anything, it's gotten worse. Definitely not a good pill for acne-prone skin!
1Patient Review
11/14/2017
Introvale for Abnormally Long or Heavy Periods
I've taken Jolessa for years, but my pharmacy changed me to this garbage. I take BC to keep my periods short since I suffer from PMDD, but now I'm experiencing 2 week long periods and bad cramping! This drug is a total fail!
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about introvale

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

Is Introvale generic for Seasonale?

"Sandoz has announced that the FDA has approved their generic equivalent of Duramed's Seasonale, Introvale (levonorgestrel and ethinyl estradiol tablets, USP)."

Answered by AI

What is Introvale medicine?

"Introvale is a prescription medicine used to prevent pregnancy by means of contraception. It may be used alone or with other medications, and is classified as an Estrogen/Progestin drug under the subcategory of Contraceptives, Oral. Its efficacy in children has not been established prior to menarche."

Answered by AI

Is Amethia and Ashlyna the same?

"The drug Amethia is used as a contraceptive to prevent pregnancy. The generic version of Amethia is Ethinyl Estradiol/Norethindrone."

Answered by AI

What is Introvale generic for?

"Introvale is a combined oral contraceptive that contains levonorgestrel and ethinyl estradiol. It is indicated for use by women to prevent pregnancy. Introvale is available in generic form."

Answered by AI

Clinical Trials for Introvale

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