Prefest

Acne Vulgaris, moderate Vulvovaginal atrophy, Hot flashes + 9 more

Treatment

9 FDA approvals

20 Active Studies for Prefest

What is Prefest

Norgestimate

The Generic name of this drug

Treatment Summary

Estradiol 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 Cyclen

is 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 9 uses which include Postmenopausal Osteoporosis and severe menopausal vulvovaginal atrophy .

Postmenopausal Osteoporosis

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

severe menopausal vulvovaginal atrophy

Used to treat severe menopausal vulvovaginal atrophy in combination with Estradiol

Oral Contraceptives

Used to treat Oral Contraceptives in combination with Ethinylestradiol

Acne Vulgaris

Used to treat moderate Acne vulgaris in combination with Ethinylestradiol

Osteoporosis, Postmenopausal

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

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

Effectiveness

How Prefest Affects Patients

Estradiol 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 body

Estrogen 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

Oral Contraceptives

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

Kit, , Oral, Tablet, Tablet - Oral, Kit - Oral

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

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

Menopause

, 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

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 Risk

Long-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

0 Actively Recruiting

Menopause

0 Actively Recruiting

Polycystic Ovarian Syndrome

9 Actively Recruiting

Phase 1, Not Applicable

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Hirsutism

0 Actively Recruiting

Hot flashes

30 Actively Recruiting

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

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?

1

Patient 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

Image of Citruslabs in Las Vegas, United States.

Primal Meno+ Supplement for Menopause

40 - 60
Female
Las Vegas, NV

This study evaluates the effects of Primal Harvest's Primal Meno+ supplement on symptoms of menopause and overall well-being in females aged 40-60 who are currently menopausal and experiencing at least two menopausal symptoms. Over a 12-week period, 40 participants will take one capsule of the test product daily with their first meal of the day. Participants will complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12 to assess menopausal symptoms (including hot flashes, night sweats, sleep quality, stress resilience, and emotional well-being) and overall health and well-being. This is a single-arm, open-label, virtual trial with no randomization or blinding.

Waitlist Available
Has No Placebo

Citruslabs

Primal Harvest, LLC

Image of St. Joseph's Healthcare Hamilton in Hamilton, Canada.

Internet-Delivered Cognitive Behavioural Therapy for Hot Flashes

40 - 60
Female
Hamilton, Canada

Given the impact that hot flashes and night sweats can have on daily life during the menopausal transition, our team has developed a therapist-guided online cognitive behavioural therapy (CBT)- based program to help individuals manage these symptoms. An online program may help address systemic barriers to in-person care, such as cost, time, travel, and caregiving needs. The broad aim of this pilot clinical trial is to examine the experience of a four-week therapist-guided online CBT-based program for menopause-related hot flashes and night sweats. The primary objective of this study is to evaluate the acceptability and feasibility of the four-week online program, including how participants experience the program and how well they are able to complete it at home. The secondary objective is to explore whether the program may help with hot flashes and night sweats, and related concerns such as sleep, mood, anxiety, and quality of life. Exploratory analyses will examine whether changes in these outcomes are maintained three months after completing the program. Researchers will compare participants who receive the program immediately with participants who wait four weeks before receiving it. Participants will: * Complete online questionnaires about their symptoms and well-being. * Complete four weekly online lessons and activities. * Meet briefly with a guide each week for guidance and support. * Complete follow-up questionnaires after the program and three months later.

Waitlist Available
Has No Placebo

St. Joseph's Healthcare Hamilton

Sheryl M Green, PhD, CPsych

Image of MusB Research LLC in New Port Richey, United States.

Ashoka Bark and Shatavari for Menopause

40 - 65
Female
New Port Richey, FL

This 12-week randomized, placebo-controlled clinical trial will evaluate the efficacy and safety of a daily oral supplement containing Ashoka Bark and Shatavari in women experiencing menopausal symptoms. Up to 50 participants will be randomized to receive either the active supplement or placebo, with 40 participants expected to complete the study. Participants will attend visits at Weeks 0, 6, and 12, where hormone levels (FSH and estradiol), menopausal symptoms, quality of life, anxiety, cognitive function, and sleep will be assessed using validated measures. The study will also explore changes in the vaginal microbiome and monitor safety and adherence throughout the trial. The study will be conducted at MusB Research in New Port Richey, Florida.

Recruiting
Dietary Supplement

MusB Research LLC

Vidya USA Corporation

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Image of Novum Pharmaceutical Research Services in Las Vegas, United States.

Estradiol/Levonorgestrel Patch for Menopause

40 - 75
Female
Las Vegas, NV

The two products used in this study are transdermal patches that contain selegiline. The test drug is the Estradiol/Levonorgestrel Transdermal Delivery System (TDS). The comparator drug is the Climara Pro® TDS. The purpose of this research study is to compare how the skin tolerates the test TDS and the comparator TDS. The study will evaluate and compare skin irritation and possible allergic-type skin reactions (sensitization) caused by the two products. The comparison will be based on how the skin responds to repeated applications of each TDS. This includes the assessment of skin irritation during the Induction Period and the evaluation of possible allergic or sensitization reactions after the Challenge Period. In addition, the adhesion of each patch (how well the patch sticks to the skin over time) will be regularly checked, as this is important for both product performance and skin safety.

Phase 1
Recruiting

Novum Pharmaceutical Research Services

Corium Innovations, Inc.

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Image of Carnegie Mellon University in Pittsburgh, United States.

Hormonal Effects on Brain Stimulation for Depression

18 - 40
All Sexes
Pittsburgh, PA

This study is investigating how two types of non-invasive brain stimulation, transcranial electrical stimulation (TES) and transcranial magnetic stimulation (TMS), affect brain activity, and whether combining them produces stronger or more consistent effects than either one used alone. The motivation for this comes from the observation that TMS, which is FDA-approved for treating depression, tends to work less well in postmenopausal women because lower estrogen levels reduce the brain's ability to respond to stimulation. The research team believes that pairing TMS with TES, which targets a different set of brain cells, may be able to overcome this hormonal barrier and make stimulation more effective. Participants will come into the lab for up to 24 visits over 8 months, beginning with an initial visit to establish the right stimulation settings, followed by a series of stimulation sessions in which brain activity is measured before and after receiving either TES, TMS, or both together. For female participants, sessions will be scheduled at specific points in the menstrual cycle to capture the natural monthly rise and fall of estrogen, while male participants will be scheduled on a comparable fixed interval as a comparison group. The insights gained from this study could directly inform the development of better, more reliable brain stimulation treatments for women with depression.

Waitlist Available
Has No Placebo

Carnegie Mellon University

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