Osphena

severe Vaginal dryness, Dyspareunia, severe Dyspareunia + 2 more

Treatment

20 Active Studies for Osphena

What is Osphena

Ospemifene

The Generic name of this drug

Treatment Summary

Ospemifene is a drug used to treat pain during intercourse caused by menopause. It is a hormone-free medication that was approved by the FDA in 2013.

Osphena

is the brand name

image of different drug pills on a surface

Osphena Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Osphena

Ospemifene

2013

3

Effectiveness

How Osphena Affects Patients

Ospemifene is used to treat osteoporosis and may help to prevent breast cancer. It works by reducing the activity of the estrogen receptor (ER) alpha and beta, which are found in the body. Studies have shown that taking ospemifene in higher doses can reduce the risk of tumors. It also interacts with cells that build and break down bone, which helps reduce bone turnover.

How Osphena works in the body

Ospemifene is a drug that works specifically on estrogen receptors. It either boosts or blocks estrogen's activity in different parts of the body. When used in the uterus, it stimulates the tissue.

When to interrupt dosage

The proposed dosage of Osphena is contingent upon the established condition, including Menopause, extreme Dyspareunia and moderate Dyspareunia. The measure also changes according to the technique of delivery featured in the table below.

Condition

Dosage

Administration

severe Vaginal dryness

60.0 mg,

, Tablet, film coated - Oral, Oral, Tablet, film coated, Tablet - Oral, Tablet

Dyspareunia

60.0 mg,

, Tablet, film coated - Oral, Oral, Tablet, film coated, Tablet - Oral, Tablet

severe Dyspareunia

60.0 mg,

, Tablet, film coated - Oral, Oral, Tablet, film coated, Tablet - Oral, Tablet

moderate Vaginal dryness

60.0 mg,

, Tablet, film coated - Oral, Oral, Tablet, film coated, Tablet - Oral, Tablet

Hot flashes

60.0 mg,

, Tablet, film coated - Oral, Oral, Tablet, film coated, Tablet - Oral, Tablet

Warnings

Osphena Contraindications

Condition

Risk Level

Notes

estrogen-dependent neoplasia

Do Not Combine

Venous Thrombosis

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Pulmonary Embolism

Do Not Combine

Deep Vein Thrombosis

Do Not Combine

Thromboembolism

Do Not Combine

Pulmonary Embolism

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Ospemifene may interact with Pulse Frequency

There are 20 known major drug interactions with Osphena.

Common Osphena Drug Interactions

Drug Name

Risk Level

Description

Amoxapine

Major

The metabolism of Amoxapine can be decreased when combined with Ospemifene.

Astemizole

Major

The metabolism of Astemizole can be decreased when combined with Ospemifene.

Clomipramine

Major

The metabolism of Clomipramine can be decreased when combined with Ospemifene.

Clonidine

Major

The metabolism of Clonidine can be decreased when combined with Ospemifene.

Cyclophosphamide

Major

The metabolism of Cyclophosphamide can be decreased when combined with Ospemifene.

Osphena Toxicity & Overdose Risk

Common side effects (occurring in more than 1% of people) of taking this drug include increased body temperature, vaginal discharge, muscle cramps, genital discharge, and excessive sweating.

image of a doctor in a lab doing drug, clinical research

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

16 active clinical trials are evaluating the potential of Osphena to ameliorate Menopause, severe and moderate Dyspareunia.

Condition

Clinical Trials

Trial Phases

severe Vaginal dryness

0 Actively Recruiting

Dyspareunia

0 Actively Recruiting

moderate Vaginal dryness

0 Actively Recruiting

severe Dyspareunia

0 Actively Recruiting

Hot flashes

31 Actively Recruiting

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

Osphena Reviews: What are patients saying about Osphena?

5

Patient Review

2/6/2019

Osphena for Painful Sexual Intercourse due to Menopause

This drug was a game-changer for me! It completely got rid of painful intercourse and vaginal dryness within two weeks. I found other vaginal treatments to be ineffective and messy in comparison. Osphena is easy to use, discreet, and covered by my insurance with no co-pay. I would recommend it to any woman dealing with these issues.

5

Patient Review

1/29/2019

Osphena for Painful Sexual Intercourse due to Menopause

I've been on this medication for almost two years now. I started having really bad leg, arm, and neck cramps, so my doctor told me to take it a few days per week. That seemed to help. Then I had terrible watery discharge that seemed worse at night. It's also helped with pain during intercourse.

5

Patient Review

9/3/2021

Osphena for Painful Sexual Intercourse due to Menopause

Osphena has completely changed my life for the better. Menopause had really taken a toll on me and it was impacting my marriage due to pain and dryness during sex. This medication has been a godsend, allowing me to be happy despite menopause.

5

Patient Review

7/25/2018

Osphena for Painful Sexual Intercourse due to Menopause

5

Patient Review

8/17/2018

Osphena for Painful Sexual Intercourse due to Menopause

Though excellent, the price unfortunately kept me from being able to continue using this drug.

5

Patient Review

4/9/2019

Osphena for Vaginal Inflammation due to Loss of Hormone Stimulation

Ospene has been a godsend for my stress incontinence. I had surgery to address the problem when I was younger, but it returned after menopause. This medication has allowed me to exercise and live my life without worry of wetting myself.

4.7

Patient Review

4/30/2019

Osphena for Painful Sexual Intercourse due to Menopause

There was a significant improvement after starting this treatment. I can now have sex without pain! It also started working very quickly, within a month. The only downside is that I sometimes experience hot flashes which are quite uncomfortable.

4.3

Patient Review

10/1/2021

Osphena for Painful Sexual Intercourse due to Menopause

This drug was effective in treating my painful intercourse and vaginal dryness. It also helped with my frequent UTIs. However, I found that if I missed a day or two, my moods would become very depressed. Has anyone else experienced this? Great as long as I take it but I'm worried about what might happen if I can't get or afford this med anymore.

3.7

Patient Review

9/23/2019

Osphena for Painful Sexual Intercourse due to Menopause

Though this was effective in treating my symptoms, I experienced some very uncomfortable side effects. Namely, the weight gain and hot flashes/night sweats were unbearable. I stopped taking it and will have to look for another option.

3.3

Patient Review

7/15/2021

Osphena for Painful Sexual Intercourse due to Menopause

Testosterone is much more effective than Osphena, and it doesn't cause weight gain. Testosterone has lots of benefits while Osphena really only addresses vaginal dryness. I'm glad my gynecologist is up-to-date on the latest research.

2.7

Patient Review

2/8/2020

Osphena for Painful Sexual Intercourse due to Menopause

I'm very disappointed with this medication. I've only been taking it for a week and have gained three pounds, despite no change in my diet or exercise habits. It also cost me $100. I haven't been taking it long enough to see if it's effective for my vaginal issues, but I don't want to risk gaining more weight.

2.3

Patient Review

12/17/2018

Osphena for Painful Sexual Intercourse due to Menopause

Osphena has not only helped with painful intercourse, but I have found that my sex drive has increased as well. I actually want to have sex now, which is something that I haven't felt in years. The side effects are manageable, and overall I would say that this drug is worth it.

2.3

Patient Review

3/8/2019

Osphena for Painful Sexual Intercourse due to Menopause

I tried Osphena after other options failed me. The vaginal dryness was so bad that it caused tearing and made intercourse unbearable. Life was really tough, but things got better after using Osphena for a month. I've been on it for almost 3 years now and I'm really thankful that my doctor found something that worked for me.

1.7

Patient Review

4/28/2019

Osphena for Painful Sexual Intercourse due to Menopause

I have the BRCA 1 gene. I had a total hysterectomy and my doctor recommended this drug. It worked like it was supposed to, but I was also taking CBD oil for hot flashes. Since starting this treatment, I've been having more hot flashes, anxiety, headaches, and depression. I'm seeing my doctor again on May 1st to discuss these concerns.

1.3

Patient Review

8/17/2019

Osphena for Painful Sexual Intercourse due to Menopause

I gave this medication a month, and saw no results for my vaginal dryness. In fact, I developed other issues like a yeast infection and diarrhea. I don't think the benefits outweigh the risks here, so I'll be stopping this treatment.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about osphena

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

Is Osphena a hormone replacement?

"Osphena is not a form of estrogen. It is an alternative hormone-free option for women who do not want to take estrogen or use estrogen-based products."

Answered by AI

Is Osphena a hormone?

"Osphena works by replenishing lacked vaginal moisture, which can result in painful intercourse. The active ingredient in Osphena, ospemifene, is a selective estrogen receptor modulator (SERM).

Osphena is a non-hormonal treatment option for women who do not want to take estrogen or use estrogen-based products. Osphena replenishes vaginal moisture, which can result in painful intercourse. The active ingredient in Osphena, ospemifene, is a selective estrogen receptor modulator (SERM)."

Answered by AI

What are side effects of Osphena?

"The following are symptoms of blood clots: leg pain or swelling, skin that's warm to the touch, trouble breathing. The following are symptoms of a stroke: sudden weakness on one side of your body, headache, changes in your speech or vision, confusion. The following are symptoms of a heart attack: chest pain, shortness of breath, arm pain, cold sweat."

Answered by AI

Is Osphena safer than estrogen?

"The risks of stroke and deep vein thrombosis (DVT) are increased with estrogen-alone therapy. Cerebral thromboembolic and hemorrhagic stroke incidence rates were 1.13 and 3.39 per thousand women years, respectively, with OSPHENA 60 mg, vs. 3.15 and 0 per thousand women years, respectively, with placebo."

Answered by AI

Clinical Trials for Osphena

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
New This Month

MusB Research LLC

Vidya USA Corporation

Image of Alberta Diabetes Institute in Edmonton, Canada.

Resistance Exercise for Type 1 Diabetes

18+
Female
Edmonton, Canada

Improvements in diabetes care and technology have led to people with type 1 diabetes living longer. There are now more seniors than ever living with this complex health condition. With aging, type 1 diabetes affects both bone (more brittle), and muscle (loss of size and strength). This loss happens faster and to a greater extent in females than in males, and greatly increases the risk of frailty and falls. It may also occur more quickly in individuals who have higher blood glucose (sugar) levels. Frailty is an important factor to address. In older females, even mild frailty decreases the ability to perform day-to-day tasks, and increases the risk of fractures, falls, hospitalization, and even death. Performing regular exercise helps to maintain the strength and quality of both muscles and bones with aging. The best type of exercise to help maintain the ability to perform activities of daily living (known as functional mobility) for this population is currently unknown. Resistance exercise (weightlifting) helps to prevent decreases in mobility in seniors without diabetes. However, in the context of type 1 diabetes, high blood sugar levels could negatively impact these potential strength benefits and low blood glucose could lead to falls. As such, any exercise program that causes swings in glucose levels may hinder rather than help. The goal of this study is to evaluate the effect of weightlifting over a 6-month timeframe on functional mobility in postmenopausal females with type 1 diabetes, compared to a group that does not train. the investigators will also assess its effects on blood sugar variability and the risk of hypoglycemia. Like different medications, not all exercise is equal. Creating more knowledge about the benefits of specific types of exercise in this population will allow us to be more precise in our exercise recommendations for living longer and more independently with type 1 diabetes.

Waitlist Available
Has No Placebo

Alberta Diabetes Institute (+2 Sites)

Jane E Yardley, PhD

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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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We made a collection of clinical trials featuring Osphena, we think they might fit your search criteria.
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Image of The Ohio State University in Columbus, United States.

Mindfulness-Based Group Visits for Menopause

40 - 60
Female
Columbus, OH

While perimenopause and menopause are natural biological transitions, women may experience a wide range of physical, emotional, and cognitive symptoms. Although pharmacological options for symptom relief are available, these options may not be acceptable or suitable for all women. Integrative approaches for symptom relief, offered through group medical visits, may complement traditional therapies by increasing access to providers, allowing more time for focused education, and fostering supportive discussions with other women experiencing similar symptoms of perimenopause or menopause. The purpose of this study is to assess the effectiveness of eight monthly group medical visits that incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Individual outcomes, obtained before the group medical visits begin, at each monthly group medical visit, and four months after the group medical visits are completed, will include measures of participants' perimenopause or menopause symptoms, stress, inflammation, microbiome (good bacteria in the body), height/weight, body mass index (BMI), systolic and diastolic blood pressure, and self-reported perceptions of physical, mental, and social health. Each 120-minute monthly group medical visit, led by a specially trained nurse practitioner and a mindfulness instructor, will include a brief physical assessment, educational discussions related to menopause and lifestyle medicine, experiential mindfulness practices, and the development of individual health and well-being goals.

Waitlist Available
Has No Placebo

The Ohio State University

Image of Banner University Medical Center Phoenix in Phoenix, United States.

DHEA vs Estradiol for Menopause

40 - 90
Female
Phoenix, AZ

This study is being done to compare two vaginal treatments, vaginal estrogen and vaginal DHEA, that are used to treat vaginal and urinary symptoms related to menopause. These symptoms may include vaginal dryness, discomfort, painful intercourse, or urinary problems and can affect quality of life and sexual health. Women who choose to participate will be randomly assigned to use one of the two treatments for a set period of time. Participants will complete questionnaires about their symptoms and sexual health and have simple vaginal testing at the beginning and end of the study. The goal of this research is to better understand how these treatments affect vaginal health and sexual function so healthcare providers can make informed treatment decisions and improve care for postmenopausal women.

Recruiting
Has No Placebo

Banner University Medical Center Phoenix

Molloy Shaida

Have you considered Osphena clinical trials?

We made a collection of clinical trials featuring Osphena, we think they might fit your search criteria.
Go to Trials