Prefest

Acne Vulgaris, moderate Vulvovaginal atrophy, Hot flashes + 9 more
Treatment
8 FDA approvals
20 Active Studies for Prefest

What is Prefest

NorgestimateThe Generic name of this drug
Treatment SummaryEstradiol is a hormone naturally produced by females. It is used in hormone therapy to treat conditions caused by low estrogen levels, such as hot flashes and vaginal atrophy. Estradiol is available in various forms including oral tablets, injections, vaginal rings, patches, sprays, gels, and creams. For oral or injection use, estradiol is often combined with an ester side-chain, such as ethinyl estradiol (EE), to increase its bioavailability. EE is the synthetic form of estradiol and is commonly used in oral contraceptive pills (OCPs).
Ortho Tri Cyclenis the brand name
image of different drug pills on a surface
Prefest Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Ortho Tri Cyclen
Norgestimate
1989
113

Approved as Treatment by the FDA

Norgestimate, commonly known as Ortho Tri Cyclen, is approved by the FDA for 8 uses which include Oral Contraceptives and Osteoporosis, Postmenopausal .
Oral Contraceptives
Used to treat Oral Contraceptives in combination with Ethinylestradiol
Osteoporosis, Postmenopausal
Used to treat Postmenopausal Osteoporosis in combination with Estradiol
Acne Vulgaris
Used to treat moderate Acne vulgaris in combination with Ethinylestradiol
moderate Vulvovaginal atrophy
Used to treat moderate Vulvovaginal atrophy in combination with Estradiol
Hot flashes
Used to treat Menopause in combination with Estradiol
moderate Menopausal Vasomotor Symptoms
Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol
Menopause
Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Estradiol
severe menopausal vulvovaginal atrophy
Used to treat severe menopausal vulvovaginal atrophy in combination with Estradiol

Effectiveness

How Prefest Affects PatientsEstradiol helps to reduce hot flashes and other menopausal symptoms, as well as improve vaginal dryness and pain during sex. It also helps to increase bone density, improve the balance of fats in the blood, and reduce levels of follicle-stimulating hormone. However, it can cause a higher risk of cardiovascular issues like strokes, DVT, and hypertension. Estradiol can also induce a hyper-coagulable state, which is a state of increased risk of forming blood clots. The increased risk of hypertension is thought to be caused by increased levels of angiotensin and sodium retention.
How Prefest works in the bodyEstrogen is a hormone found in many parts of the body, including the breasts, uterus, ovaries, skin, prostate, bones, fat, and brain. During the reproductive years, the ovaries produce most of the estrogen in a woman's body. After menopause, the main source of estrogen is from a hormone made in the adrenal glands called androstenedione. This hormone is converted to estrone and its sulfate form, estrone sulfate. These two forms are the most common estrogens found in postmenopausal women. Estradiol is more powerful than estrone and

When to interrupt dosage

The suggested measure of Prefest is contingent upon the diagnosed condition, for example Premature Menopause, Pharmaceutical Preparations and Postmenopause. The amount of dosage is contingent upon the technique of administration featured in the following table.
Condition
Dosage
Administration
Polycystic Ovarian Syndrome
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
moderate Vulvovaginal atrophy
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
Menopause
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
severe menopausal vulvovaginal atrophy
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
Osteoporosis, Postmenopausal
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
Oral Contraceptives
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
Menorrhagia
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
Hirsutism
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
moderate Menopausal Vasomotor Symptoms
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
Hot flashes
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
Acne Vulgaris
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral
Dysmenorrhea
, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg
, Kit, Oral, Tablet, Tablet - Oral, Kit - Oral

Warnings

Prefest has eighteen contraindications and must not be combined with the circumstances enumerated in the following table.Prefest Contraindications
Condition
Risk Level
Notes
Breast
Do Not Combine
Breast Cancer
Do Not Combine
high risk of arterial thrombotic disease
Do Not Combine
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Hypersensitivity
Do Not Combine
Venous Thrombosis
Do Not Combine
Pulse Frequency
Do Not Combine
estrogen-sensitive cancer
Do Not Combine
Metrorrhagia
Do Not Combine
Liver Neoplasms
Do Not Combine
There are 20 known major drug interactions with Prefest.
Common Prefest Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The serum concentration of Abemaciclib can be increased when it is combined with Norgestimate.
Acalabrutinib
Major
The metabolism of Acalabrutinib can be increased when combined with Norgestimate.
Alectinib
Major
The metabolism of Alectinib can be increased when combined with Norgestimate.
Aminophylline
Major
The metabolism of Aminophylline can be increased when combined with Norgestimate.
Astemizole
Major
The metabolism of Astemizole can be increased when combined with Norgestimate.
Prefest Toxicity & Overdose RiskLong-term exposure to estradiol has been shown to have toxic effects at a dose of 0.003mg/kg/day in rats. The lowest toxic dose for women is 21mg/kg/21D and the highest dose that can cause death is 960mg/kg. An overdose of estradiol may cause symptoms such as nausea, vomiting, abdominal pain, breast tenderness, blood clots, and vaginal bleeding. It is advised to stop taking estradiol and receive supportive care in case of an overdose.

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

At present, 867 active clinical trials are underway to ascertain the potential of Prefest to ameliorate Osteoporosis, Amenorrhea and Urogenital Atrophy.
Condition
Clinical Trials
Trial Phases
Dysmenorrhea
0 Actively Recruiting
Acne Vulgaris
0 Actively Recruiting
Osteoporosis, Postmenopausal
0 Actively Recruiting
Oral Contraceptives
1 Actively Recruiting
Not Applicable
Menopause
0 Actively Recruiting
Polycystic Ovarian Syndrome
7 Actively Recruiting
Not Applicable, Early Phase 1, Phase 1
moderate Menopausal Vasomotor Symptoms
0 Actively Recruiting
Hirsutism
0 Actively Recruiting
Hot flashes
14 Actively Recruiting
Phase 1, Phase 2, Not Applicable, Early Phase 1, Phase 4
moderate Vulvovaginal atrophy
0 Actively Recruiting
Menorrhagia
0 Actively Recruiting
severe menopausal vulvovaginal atrophy
0 Actively Recruiting

Prefest Reviews: What are patients saying about Prefest?

1Patient Review
11/4/2011
Prefest for "Change of Life" Signs
Within the past four months, something changed in the Prefest formulation and it caused a range of problems for me including pain in my legs, anxiety, insomnia, water retention, and bleeding. I had been taking this med for five years without any issues prior to this change.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about prefest

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

Does estradiol cause breast cancer?

"This means that if you use estradiol for more than five years, you have a higher risk of developing breast cancer than someone who doesn't use this medication."

Answered by AI

How does estradiol work?

"This medication works by preventing menopausal symptoms such as hot flashes and night sweats. It can also be used to treat pain during sexual intercourse caused by menopause."

Answered by AI

How long does Femhrt take to work?

"Norethindrone acetate and ethinyl estradiol are quickly absorbed into the body from femhrt tablets, with maximum plasma concentrations of norethindrone and ethinyl estradiol typically occurring 1 to 2 hours after taking the medication."

Answered by AI

What is Prefest used for?

"Prefest is a combination of two medications: estradiol (an estrogen) and norgestimate (a progestin). Estradiol replaces the estrogen your body loses during menopause and relieves hot flashes, vaginal dryness, and strengthens bones. Norgestimate protects the uterus from damage and helps prevent uterine cancer."

Answered by AI

Clinical Trials for Prefest

Have you considered Prefest clinical trials? We made a collection of clinical trials featuring Prefest, we think they might fit your search criteria.
Have you considered Prefest clinical trials? We made a collection of clinical trials featuring Prefest, we think they might fit your search criteria.
Image of University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory in Aurora, United States.

MitoQ + Exercise for Menopause-Related Vascular Health

50 - 120
Female
Aurora, CO
This trial tests whether combining moderate aerobic exercise with the antioxidant MitoQ can improve blood vessel function in postmenopausal women who lack estrogen. MitoQ aims to reduce oxidative stress and enhance blood flow by improving mitochondrial function. The study will compare the effects of exercise with MitoQ, exercise alone, and MitoQ alone. MitoQ is a mitochondria-targeted antioxidant that has been studied for its potential to enhance exercise-induced muscle adaptations and improve peak power in untrained middle-aged men.
Phase < 1
Waitlist Available
University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research LaboratoryKerrie L Moreau, PhD
Have you considered Prefest clinical trials? We made a collection of clinical trials featuring Prefest, we think they might fit your search criteria.