Duavee

Hot flashes, Osteoporosis, Postmenopausal, Menopause + 1 more

Treatment

5 FDA approvals

18 Active Studies for Duavee

What is Duavee

Bazedoxifene

The Generic name of this drug

Treatment Summary

Bazedoxifene is a medication that helps to prevent postmenopausal osteoporosis by acting on estrogen receptors in the body. It is sold as part of the combination drug DUAVEE and is approved for use in the European Union, Japan, and the United States. Bazedoxifene is used to treat moderate to severe vasomotor symptoms caused by menopause, as well as to prevent postmenopausal osteoporosis in women.

Duavee

is the brand name

image of different drug pills on a surface

Duavee Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Duavee

Bazedoxifene

2013

3

Approved as Treatment by the FDA

Bazedoxifene, also known as Duavee, is approved by the FDA for 5 uses including Postmenopausal Osteoporosis and moderate Menopausal Vasomotor Symptoms .

Postmenopausal Osteoporosis

Used to treat Postmenopausal Osteoporosis in combination with Conjugated estrogens

moderate Menopausal Vasomotor Symptoms

Used to treat moderate Menopausal Vasomotor Symptoms in combination with Conjugated estrogens

Osteoporosis, Postmenopausal

Used to treat Postmenopausal Osteoporosis in combination with Conjugated estrogens

Menopause

Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Conjugated estrogens

Hot flashes

Used to treat Menopause in combination with Conjugated estrogens

Effectiveness

How Duavee works in the body

Bazedoxifene is a type of drug that changes how the body responds to estrogen. By doing this, it reduces bone loss and increases bone density. This helps protect against fractures. In some tissues, like the uterus and breast, bazedoxifene acts as a blocker of estrogen's effects.

When to interrupt dosage

The suggested amount of Duavee is contingent upon the identified condition, including moderate Menopausal Vasomotor Symptoms, Menopause and Postmenopausal Osteoporosis. The dosage fluctuates as per the technique of delivery (e.g. Oral or Tablet, film coated) outlined in the table beneath.

Condition

Dosage

Administration

Hot flashes

20.0 mg,

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, multilayer, extended release - Oral, Tablet, multilayer, extended release

Osteoporosis, Postmenopausal

20.0 mg,

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, multilayer, extended release - Oral, Tablet, multilayer, extended release

Menopause

20.0 mg,

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, multilayer, extended release - Oral, Tablet, multilayer, extended release

moderate Menopausal Vasomotor Symptoms

20.0 mg,

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, multilayer, extended release - Oral, Tablet, multilayer, extended release

Warnings

Duavee has fourteen contraindications, so it should not be taken while one is encountering the conditions in the table below.

Duavee Contraindications

Condition

Risk Level

Notes

Pulmonary Embolism

Do Not Combine

Protein C Deficiency

Do Not Combine

Breast Cancer

Do Not Combine

estrogen-dependent neoplasia

Do Not Combine

Thromboembolism

Do Not Combine

Pulmonary Embolism

Do Not Combine

Venous Thrombosis

Do Not Combine

Venous Thrombosis

Do Not Combine

Protein Deficiency

Do Not Combine

Thromboembolism

Do Not Combine

Metrorrhagia

Do Not Combine

Thrombophilia

Do Not Combine

Liver Disease

Do Not Combine

Antithrombin III Deficiency

Do Not Combine

There are 2 known major drug interactions with Duavee.

Common Duavee Drug Interactions

Drug Name

Risk Level

Description

Ospemifene

Major

The risk or severity of adverse effects can be increased when Bazedoxifene is combined with Ospemifene.

Fluoroestradiol F-18

Moderate

Bazedoxifene may decrease effectiveness of Fluoroestradiol F-18 as a diagnostic agent.

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

Currently, 20 active trials are analyzing the effectiveness of Duavee in alleviating moderate Menopausal Vasomotor Symptoms, Postmenopausal Osteoporosis and Menopausal related conditions.

Condition

Clinical Trials

Trial Phases

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Osteoporosis, Postmenopausal

0 Actively Recruiting

Hot flashes

19 Actively Recruiting

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

Menopause

0 Actively Recruiting

Duavee Reviews: What are patients saying about Duavee?

5

Patient Review

11/1/2016

Duavee for "Change of Life" Signs

I started feeling dizzy not long after taking this drug as directed by my doctor. How long will these side effects last?

5

Patient Review

1/7/2017

Duavee for "Change of Life" Signs

This medication quickly and effectively relieved my hot flashes and mood swings with no negative side effects.

4

Patient Review

1/17/2018

Duavee for "Change of Life" Signs

I've been taking this medication for three months to combat hot flashes. At first, it seemed to make them worse, but after the first week they decreased noticeably and have all but stopped now. I also experienced some acne during weeks two and three, but that's gone away as well. The only other symptom has been occasional leg cramping at night, which I hope doesn't get worse.

4

Patient Review

3/14/2018

Duavee for "Change of Life" Signs

I was on Duavee for almost three years and it worked well for me. I stopped taking it last week because my insurance stopped covering it, and I've gained 25 pounds since starting the medication. My eyesight has also gotten worse quickly, though I'm not sure if that's a side effect of the drug or just a result of getting older. I'm hoping my body can adjust to not taking the medication and that I'll be able to lose the weight gain.

3.7

Patient Review

12/8/2017

Duavee for "Change of Life" Signs

I've been using Duavee for four days now to mitigate hot flashes, night sweats, moodiness and low libido. So far I'm seeing great results with all of those issues; however, today I am feeling very nauseous, have a stomach ache, and a horrible headache. I'm wondering if anybody else has experienced these side effects from the drug? If so, did you have to go off the medication because of them?

3.3

Patient Review

1/12/2017

Duavee for "Change of Life" Signs

I've been taking Duavee for the past three months to help with my menopause symptoms: low libido, irritability, and vaginal dryness.

3.3

Patient Review

8/10/2017

Duavee for "Change of Life" Signs

I started taking Duavee seven months ago to combat hot flashes. It did work for a while, but they've come back pretty badly over the last two months. I'm also 20 pounds heavier since starting this medication, so I think I'll be discontinuing use.

3

Patient Review

7/30/2018

Duavee for "Change of Life" Signs

I wasn't told that I would gain weight and bloat from this medication. If I had known, I would have chosen to suffer through the night sweats instead.

3

Patient Review

7/25/2016

Duavee for "Change of Life" Signs

This drug helped to reduce my hot flashes for the first six months, and I found it easier to sleep. However, they started to come back after a while, and I also experienced some uncomfortable side effects like leg swelling and cramping. In the end, I stopped taking it.

2.7

Patient Review

3/24/2019

Duavee for Post-Menopausal Osteoporosis Prevention

I'm going off this medication because I've gained 14 pounds in 8 months. This is a lot for me, especially given that I haven't changed my eating or exercise habits.

2.7

Patient Review

5/29/2018

Duavee for Osteoporosis

I found that I was constantly tired while taking Duavee; no matter when I took my dose, the fatigue didn't go away. In addition to that, I started gaining weight; however, the side effects were so bad that I couldn't continue taking the medication after just four months.

2.7

Patient Review

6/9/2017

Duavee for "Change of Life" Signs

I've been taking this medication for three months now, and I'm still experiencing hot flushes and night sweats. Unfortunately, I've also gained weight since starting the treatment.

2

Patient Review

11/26/2016

Duavee for "Change of Life" Signs

I'm going to stop taking Duavee. I've been on it for two years and I'm starting to experience a lot of negative side effects, like hot flashes, leg cramps, and blurry vision.

1.7

Patient Review

2/15/2018

Duavee for "Change of Life" Signs

Unfortunately, this medication caused me to retain water and I gained 8 pounds as a result. I also experienced nasty acne breakouts and restless nights. The only plus side was that it helped control my hot flashes; however, the negatives far outweighed the positives so I stopped taking it after four months.

1

Patient Review

10/5/2016

Duavee for "Change of Life" Signs

Though I have more energy, this treatment unfortunately has not alleviated any other negative menopause symptoms.

1

Patient Review

6/26/2018

Duavee for "Change of Life" Signs

I did some research on this medication before taking it, as I do with all medications prescribed to me. However, after only four days of taking the recommended dosage, my heart rate and blood pressure spiked to dangerous levels. My resting heart rate was 114 beats per minute!
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about duavee

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

What is the generic name for Duavee?

"Duavee is a medication that contains a female hormone called estrogen, as well as an agonist/antagonist that is used to treat symptoms associated with menopause and to prevent postmenopausal osteoporosis."

Answered by AI

What is the difference between PremPro and Duavee?

"This medication can be used by women who still have their uterus. Most other estrogen medications increase the risk of breast cancer when used by themselves, but this one does not."

Answered by AI

Why is Duavee no longer available?

"Unfortunately, during the trial, Duavee became no longer available due to an issue with packaging and dissolution of the active agents."

Answered by AI

Is Duavee available now?

"DUAVEE is unavailable at the moment. Please check with your healthcare provider about treatment options until DUAVEE becomes available again."

Answered by AI

Clinical Trials for Duavee

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

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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 Laboratory

W. Larry Kenney, Ph.D.

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We made a collection of clinical trials featuring Duavee, we think they might fit your search criteria.
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Image of Student Health and Wellness Building - Department of Kinesiology in Charlottesville, United States.

Nitrate Supplementation and Exercise for Menopause

45 - 75
Female
Charlottesville, VA

Menopause greatly increases cardiovascular disease risk (CVD). Current exercise guidelines are inadequate to ameliorate this risk and higher intensity exercise may be necessary for cardiovascular benefits in postmenopausal females. Oral nitrate supplementation enhances exercise performance and CVD risk profile in several clinical conditions. The investigators recently reported that 3-days of nitrate supplementation in postmenopausal females enhances acute post-exercise vascular function, in an intensity dependent manner. The effects of nitrate supplementation and exercise training over a longer training program remains unexplored. This investigation will examine the impact of exercise training intensity with and without inorganic nitrate supplementation, on CVD and fitness outcomes. Postmenopausal females will be tested for maximal oxygen uptake and lactate threshold before randomization to one of four groups: that inorganic nitrate-rich beetroot juice, or beetroot juice with nitrate extracted; and assigned to one-month of calorie matched high-intensity or moderate-intensity exercise training. Vascular function and fitness will be evaluated before and after training.

Recruiting
Paid Trial

Student Health and Wellness Building - Department of Kinesiology

Jason Allen, PhD

Image of University of Colorado Anschutz Medical Campus in Aurora, United States.

Estradiol Patch for Menopause

20 - 45
Female
Aurora, CO

The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen.

Phase 4
Recruiting

University of Colorado Anschutz Medical Campus

Kerrie Moreau, PhD

Image of Hybl Sports Medicine and Performance Center in Colorado Springs, United States.

Hot Water Therapy for Menopause-Related Hot Flashes

40 - 80
Female
Colorado Springs, CO

The purpose of this research is to determine whether hot water therapy (i.e. taking prolonged hot baths on multiple consecutive days) decreases hot flash symptoms and improves mood in women who are undergoing or who have underwent menopause. It is hypothesized that women who undergo hot water therapy will have reduced hot flash symptoms and improved mood. Initial tracking period: Women who volunteer to participate in this study will be asked to track the frequency and intensity of their hot flash and other menopause-related symptoms for an initial two week period. Afterwards, they will start their heat therapy program. Physiological assessments: On days 1, 7, and 13 of the heat therapy sessions, the participants will enter a climate controlled room to have their thermoregulatory responses assessed. This will consist of slowly walking on a motorized treadmill in 99.5°F (37.5°C) and 30% relative humidity conditions, for 30 min, after which the humidity in the climate chamber will be progressively increased until their core temperature begins to increase (\~2 hour total time). Before and/or during these trials, core temperature, heart rate, whole-body sweat losses, thermal comfort, local sweat rate, and skin blood flow will be measured, and a 6 ml (\~1 tsp) blood sample will be taken, to assess how the participants respond to the heat stress. These sessions should take less than 3 hours to complete. Hot water therapy sessions: Upon enrolling in the study, the participants will be assigned to one of two groups: water bathing at 105°F or 97°F in the lab. On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves to a water level at the shoulders for \~30 min, followed by immersion to the hip level for \~60 min (total immersion time of 90 min). Post-intervention tracking period: after completing the heat therapy sessions, the participants will be asked to continue to take baths at home once every 4 days for 1 month. During this time, the participants will be asked to record the intensity and frequency of their hot flashes daily and other menopause-related symptoms weekly. At the end of this month the participants will be given a final exit survey, in order for them to provide the researchers information about their experience participating in the study.

Recruiting
Paid Trial

Hybl Sports Medicine and Performance Center

Nathan Morris, PhD

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We made a collection of clinical trials featuring Duavee, we think they might fit your search criteria.
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