Prefest

Acne Vulgaris, moderate Vulvovaginal atrophy, Hot flashes + 9 more
Treatment
9 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 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 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
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
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
1 Actively Recruiting
Not Applicable
Acne Vulgaris
0 Actively Recruiting
Osteoporosis, Postmenopausal
0 Actively Recruiting
Oral Contraceptives
0 Actively Recruiting
Menopause
0 Actively Recruiting
Polycystic Ovarian Syndrome
6 Actively Recruiting
Not Applicable, Phase 1
moderate Menopausal Vasomotor Symptoms
0 Actively Recruiting
Hirsutism
0 Actively Recruiting
Hot flashes
19 Actively Recruiting
Not Applicable, Phase 4, Phase 2, Early Phase 1, Phase 3
moderate Vulvovaginal atrophy
0 Actively Recruiting
Menorrhagia
3 Actively Recruiting
Phase 1, Phase 2, Not Applicable
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

Image of Erevna Innovations Inc. in Montreal, Canada.

Sculptra + Restylane for Post-Menopausal Skin Concerns

40 - 65
Female
Montreal, Canada
The post-menopausal state is marked by a sharp decline in estrogen, leading to significant structural and functional changes in the skin, including collagen loss, dryness, thinning, and reduced elasticity. To address these concerns, aesthetic injectables products such as Sculptra® Aesthetic (poly-L-lactic-acid \[PLLA- SCA\]) and Restylane Skinboosters®\[HASBV\] (small-particle hyaluronic acid - SP-HA) can be used. PLLA-SCA stimulates collagen production via cellular activation (biostimulator), gradually improving dermal structure. HASBV enhances hydration, elasticity, and skin texture when injected under the skin. Considering that hydration and laxity represent the primary aesthetic concerns in this patient population. Targeted treatment with SP-HA (HASBV) to improve hydration and PLLA-SCA to address laxity have been shown to produce significant clinical outcomes by directly addressing these key dermal deficiencies. This approach forms the basis of the current study.
Phase 4
Recruiting
Erevna Innovations Inc.Andreas Nikolis, MD, PhD
Image of Center for Human Nutrition in Fayetteville, United States.

Higher Protein Diet for PCOS

18 - 50
Female
Fayetteville, AR
Polycystic ovary syndrome (PCOS) is a significant public health problem and is one of the most common hormonal disturbances affecting women of reproductive age. Women with PCOS are often insulin resistant, increasing their risk for cardiometabolic health problems (e.g., type 2 diabetes, heart disease, high blood pressure, sleep apnea, anxiety, depression, and stroke) especially if they are overweight. Lifestyle modifications, including dietary changes and regular physical activity, may alleviate metabolic dysfunction in women with PCOS and are often the first line of management for patients with PCOS. Several studies have identified protein as a key nutrient for regulation of energy balance, maintenance of skeletal muscle mass, and improving cardiometabolic health across the lifespan. However, the effect of increased protein intake (30% of total energy intake) on cardiometabolic health in women with PCOS has not been well-defined and mechanisms for these effects have not been identified. There is an evident need for well-designed, randomized controlled trials evaluating the efficacy of increased protein intake in women with PCOS on markers of cardiometabolic health. Preliminary data from collaborative projects with the investigators on this proposal suggest that increasing protein in the diet has the potential to improve markers of cardiometabolic health, potentially through improvements in body composition and/or changes in cortisol, energy metabolism, inflammation, and neurological regulators
Recruiting
Has No Placebo
Center for Human Nutrition
Image of Center for Human Nutrition in Fayetteville, United States.

Protein Meals for Polycystic Ovary Syndrome

18 - 50
Female
Fayetteville, AR
Polycystic ovary syndrome (PCOS) is a common endocrine disorder characterized by insulin resistance, hyperandrogenism, and reproductive dysfunction. Dietary strategies that improve postprandial insulin and glucose responses are central to managing metabolic symptoms in PCOS. Meals higher in protein can attenuate postprandial glycemia and enhance satiety, but the effects may vary by protein source. Animal sources of protein typically have higher essential amino acid content and insulinogenic potential, whereas plant proteins offer fiber and phytochemicals that may influence glycemic dynamics differently. Few studies have directly compared the acute metabolic effects of plant versus animal protein in women with PCOS. Given the distinct pathophysiology of PCOS, extrapolating findings from healthy populations may be misleading. Understanding protein-specific effects on postprandial insulin, glucose, and appetite-regulating hormones in this group is essential for targeted nutrition guidance. Additionally, plant-based diets are increasingly promoted for cardiometabolic health, but their acute effects in insulin-resistant women remain underexplored. This study will assess whether plant and animal protein meals elicit differential postprandial responses in women with PCOS. Findings may inform dietary recommendations aimed at improving metabolic outcomes in this high-risk population.
Recruiting
Has No Placebo
Center for Human NutritionJamie I Baum, PhD
Have you considered Prefest clinical trials? We made a collection of clinical trials featuring Prefest, we think they might fit your search criteria.Go to Trials
Image of William J. Hybl Sports Medicine and Performance Center in Colorado Springs, United States.

Moderate Aerobic Exercise for Menstrual Symptoms

18 - 40
Female
Colorado Springs, CO
The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are: Is there a reduction in physical and/or psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives? Is there a difference in physical and/or psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users? Is a moderate aerobic exercise intervention more effective in reducing physical and/or psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives? Participants will: * Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention. * Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly. * Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length. * Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly. * Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles.
Recruiting
Has No Placebo
William J. Hybl Sports Medicine and Performance Center
Image of School of Allied Health Professions in Loma Linda, United States.

Seed Cycling for Menstrual Disorder

18 - 45
Female
Loma Linda, CA
The purpose of this research is to investigate the impact of seed cycling on menstrual regularity, cramps, and pre-menstrual symptoms in women with an irregular menstrual cycle and/or dysmenorrhea. The research seeks to provide evidence-based insights into the potential benefits of seed cycling as a holistic approach to women's reproductive health. It is expected that your participation will last 3 months. Procedures and Activities. You will be provided with and asked to consume specific seeds daily. The seeds are to be consumed as follows: follicular phase (the period from the first day of menstruation (day 1) to ovulation (day 14) in a typical 28-day cycle): 1 tablespoon flax seeds and 1 tablespoon pumpkin seeds, and luteal phase (the period between ovulation and the start of the next period; typically days 15-28): 1 tablespoon sunflower seeds and 1 tablespoon sesame seeds. Before the intervention and once monthly for a total of 3 cycles, you will be asked to complete an online menstrual health symptom questionnaire (MHSQ) and keep track of your menstrual cycle days on the built-in health tracking app on your electronic device. Risks. Some of the foreseeable risks or discomforts of your participation include the potential for mild gastrointestinal side effects, the potential for allergic reactions, and the possibility of no significant benefit. Benefits. Possible benefits include the potential for improved menstrual cycle regularity, the potential for a reduction in premenstrual syndrome (PMS) symptoms, and the potential for nutritional benefits. Societal benefits include additional knowledge on seed cycling to help manage menstrual regularity and PMS symptoms.
Waitlist Available
Has No Placebo
School of Allied Health Professions
Have you considered Prefest clinical trials? We made a collection of clinical trials featuring Prefest, we think they might fit your search criteria.Go to Trials
Image of Noll Laboratory in University Park, United States.

Estradiol and Elagolix for Menopause

42 - 64
Female
University Park, PA
The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men. Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.
Phase 4
Recruiting
Noll LaboratoryW. Larry Kenney, Ph.D.
Have you considered Prefest clinical trials? We made a collection of clinical trials featuring Prefest, we think they might fit your search criteria.Go to Trials
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