Osphena

severe Vaginal dryness, Dyspareunia, severe Dyspareunia + 2 more
Treatment
19 Active Studies for Osphena

What is Osphena

OspemifeneThe Generic name of this drug
Treatment SummaryOspemifene 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.
Osphenais 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 PatientsOspemifene 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 bodyOspemifene 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 RiskCommon 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
19 Actively Recruiting
Not Applicable, Phase 4, Phase 2, Early Phase 1, Phase 3

Osphena Reviews: What are patients saying about Osphena?

5Patient 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.
5Patient 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.
5Patient 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.
5Patient Review
7/25/2018
Osphena for Painful Sexual Intercourse due to Menopause
5Patient 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.
5Patient 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.
4.7Patient 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.
4.3Patient 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.
3.7Patient 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.
3.3Patient 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.
2.7Patient 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.
2.3Patient 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.
2.3Patient 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.
1.7Patient 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.
1.3Patient 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 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
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
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 Osphena clinical trials? We made a collection of clinical trials featuring Osphena, we think they might fit your search criteria.Go to Trials
Image of Rehabilitation R&D Service, Baltimore, MD in Baltimore, United States.

Cognitive Behavioral Therapy for Menopause

18+
Female
Baltimore, MD
Women are the fastest-growing group of U.S. Veterans. Over half of those using VA care are 45 or older, with more age-related health concerns than civilian women. The VA urgently needs gender-informed strategies to ensure women Veterans receive tailored care that addresses their intersecting mental, physical, and age related health concerns, as well as gender-linked stressors. One prominent example is menopause, a health transition period that, for many women, can be associated with negative physical and mental health concerns that can worsen their functioning and quality of life. This project will: (1) integrate stakeholder feedback to tailor Cognitive Behavioral Therapy for Menopause (CBT-Meno) for women Veterans with menopause concerns; and (2) refine and evaluate tailored CBT-Meno as a treatment to address these intersecting needs in a clinical trial.
Waitlist Available
Has No Placebo
Rehabilitation R&D Service, Baltimore, MD (+2 Sites)Haley Miles-McLean, PhD
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 KinesiologyJason 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 CampusKerrie Moreau, PhD
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
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