Simpesse

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

What is Simpesse

LevonorgestrelThe Generic name of this drug
Treatment SummaryLevonorgestrel (LNG) is a hormone medication used in contraception and hormone therapy. It is commonly known as Plan B and can be taken as a single pill for emergency contraception or as an IUD (also known as Jaydess, Kyleena, and Mirena). It can also be used in combination with other contraceptives or in an implant form which is inserted under the skin and slowly releases the hormone over a long-term period. Levonorgestrel is the most widely used emergency contraceptive worldwide and was the first to be approved by the FDA in 1982 due to its high efficacy and low levels of estrogenic
Triphasil-21is the brand name
Simpesse 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 moderate Menopausal Vasomotor Symptoms and Emergency Contraception .
moderate Menopausal Vasomotor Symptoms
Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol
Emergency Contraception
Has had at least 1 child
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
Hot flashes
Used to treat Menopause in combination with Estradiol

Effectiveness

How Simpesse Affects PatientsLevonorgestrel can help prevent pregnancy by stopping ovulation, fertilization, and implantation. If taken as a tablet within 72 hours of intercourse, it is 89% effective. If used as an intrauterine or implantable device, it is over 99% effective. Levonorgestrel can also be used as part of hormonal therapy to help prevent endometrial cancer caused by unopposed estrogen.
How Simpesse works in the bodyLevonorgestrel is used in oral contraceptives to prevent ovulation. It does this by slowing down the release of hormones that trigger ovulation. It also increases the thickness of cervical mucus, which stops sperm from entering the uterus. Over a long-term period, levonorgestrel has been shown to thicken cervical mucus. The exact way it works is not completely understood. When used in combination with estrogen for menopausal symptoms and osteoporosis, levonorgestrel helps reduce the risk of endometrial cancer. It does this by inhibiting the growth of the endometrium.

When to interrupt dosage

The proposed dosage of Simpesse is dependent upon the determined condition, like Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The magnitude of dosage fluctuates, based on the administration approach noted in the table below.
Condition
Dosage
Administration
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
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
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
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
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
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
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
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
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

Warnings

Simpesse 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 Simpesse.
Common Simpesse 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.
Simpesse Toxicity & Overdose RiskThe lowest toxic dose of levonorgestrel in rats is greater than 5000 mg/kg. If someone overdoses on levonorgestrel, they may experience nausea and bleeding. Treat the symptoms and contact poison control for help. There is no known antidote for a levonorgestrel overdose.

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

99 active clinical trials are currently underway, assessing the potential of Simpesse to address Postmenopausal Osteoporosis, Past Childbearing 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

Simpesse Reviews: What are patients saying about Simpesse?

1Patient Review
12/24/2021
Simpesse for Birth Control
I didn't have my normal brand of birth control, so I was given this one instead. Unfortunately, it seems like these pills were ineffective; I started my period as soon as I began taking them
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about simpesse

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

Is Simpesse the same as seasonique?

"The drugs Seasonique, Amethia, Camrese, Daysee, Simpesse, Ashlyna, and Jaimiess all have the same active ingredient and dosage. Seasonale, Introvale, Jolessa, and Quasense also have the same active ingredient and dosage."

Answered by AI

What is Simpesse used for?

"The combination hormone medication contains a progestin and an estrogen to prevent pregnancy."

Answered by AI

What kind of birth control is Simpesse?

"Simpesse is a 84-day extended-cycle oral contraceptive that contains low-dose levonorgestrel and ethinyl estradiol. The pills are taken daily for 12 weeks, followed by a one-week break."

Answered by AI

Clinical Trials for Simpesse

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