Climara Pro

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more

Treatment

7 FDA approvals

20 Active Studies for Climara Pro

What is Climara Pro

Levonorgestrel

The Generic name of this drug

Treatment Summary

Estradiol is a hormone naturally found in females. It is available as a prescription medication to treat conditions caused by low estrogen levels, such as hot flashes and vulvovaginal atrophy. Estradiol can be taken orally, by injection, through a vaginal ring, patch, spray, gel, or cream. It is often combined with a pro-drug ester, such as ethinyl estradiol, to make it more effective when taken orally. Ethinyl estradiol is a synthetic form of estradiol that is commonly used in combination oral contraceptive pills.

Triphasil-21

is the brand name

image of different drug pills on a surface

Climara Pro Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Triphasil-21

Levonorgestrel

1984

243

Approved as Treatment by the FDA

Levonorgestrel, also known as Triphasil-21, is approved by the FDA for 7 uses including Osteoporosis, Postmenopausal and Hot flashes .

Osteoporosis, Postmenopausal

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

Hot flashes

Used to treat Menopause in combination with Estradiol

Postmenopausal Osteoporosis

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

Menopause

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

moderate Menopausal Vasomotor Symptoms

Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol

Has had at least 1 child

Emergency Contraception

Effectiveness

How Climara Pro Affects Patients

Estradiol is used to treat symptoms related to menopause, such as hot flashes and vaginal dryness. It can also improve bone density by reducing bone resorption, and can raise levels of proteins like sex hormone binding globulin. Taking estradiol may also cause an increase in follicle-stimulating hormone. However, estradiol should be avoided by people at high risk of cardiovascular disease, deep vein thrombosis, or stroke, as it can cause a hyper-coagulable state. Additionally, taking estradiol may raise blood pressure due to an increase in angiotensin

How Climara Pro works in the body

Estrogen is a hormone found in many parts of the body. In women, most of it is produced by the ovaries before menopause. After menopause, the majority of estrogen comes from the adrenal glands. Estrogen works by binding to two types of receptors, ERα and ERβ, and by stimulating the G Protein-coupled estrogen receptor. This causes the receptor to enter the nucleus of the target cell and regulate gene transcription. As a result, proteins are produced that have specific effects on the target cells. This leads to relief of common symptoms associated with low estrogen levels such as hot flashes, chills

When to interrupt dosage

The suggested dosage of Climara Pro is reliant upon the diagnosed disorder, such as Premature Menopause, Pharmaceutical Preparations and Postmenopause. The quantity of dosage varies, according to the method of delivery detailed in the table below.

Condition

Dosage

Administration

Endometriosis

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Implant - Subcutaneous, Intrauterine, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant

Hot flashes

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Implant - Subcutaneous, Intrauterine, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant

Emergency Contraception

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Implant - Subcutaneous, Intrauterine, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant

Osteoporosis, Postmenopausal

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Implant - Subcutaneous, Intrauterine, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant

Menorrhagia

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Implant - Subcutaneous, Intrauterine, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant

Has had at least 1 child

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Implant - Subcutaneous, Intrauterine, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant

Endometrial Hyperplasia

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Implant - Subcutaneous, Intrauterine, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant

Menopause

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Implant - Subcutaneous, Intrauterine, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant

moderate Menopausal Vasomotor Symptoms

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Intrauterine device - Intrauterine, Intrauterine device, Transdermal, Patch, Patch - Transdermal, Subcutaneous, Implant - Subcutaneous, Intrauterine, Insert, extended release, Insert, extended release - Intrauterine, Tablet, film coated - Oral, Tablet, film coated, Implant

Warnings

Climara Pro has eighteen contraindications, and should not be administered if you are suffering from any of the afflictions listed in the table below.

Climara Pro Contraindications

Condition

Risk Level

Notes

Abortion, Septic

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Abortion, Spontaneous

Do Not Combine

HCG elevated

Do Not Combine

Pelvic Infection

Do Not Combine

Vaginitis

Do Not Combine

Acute Coryza

Do Not Combine

Breast Neoplasms

Do Not Combine

Uterine Cervicitis

Do Not Combine

Communicable Diseases

Do Not Combine

Gonorrhea

Do Not Combine

Breast Cancer

Do Not Combine

Intrauterine Devices

Do Not Combine

Liver Neoplasms

Do Not Combine

congenital or aquired uterine abnormality

Do Not Combine

Chlamydia Infections

Do Not Combine

Hypersensitivity

Do Not Combine

Emergency Contraception

Do Not Combine

Endocarditis, Bacterial

Do Not Combine

Vaginosis, Bacterial

Do Not Combine

suspected pregnancy

Do Not Combine

Uterine Cervicitis

Do Not Combine

Uterine Neoplasms

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Breast Neoplasms

Do Not Combine

Uterine Cervical Neoplasms

Do Not Combine

Fibroid Tumor

Do Not Combine

Endometritis

Do Not Combine

chlamydial cervical infection

Do Not Combine

PAP Test Abnormalities

Do Not Combine

Liver Failure, Acute

Do Not Combine

Uterine anomaly distorting uterine cavity

Do Not Combine

Breast Cancer

Do Not Combine

Cervical Dysplasia

Do Not Combine

Thromboembolism

Do Not Combine

Bacterial Vaginosis

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Breast

Do Not Combine

Vaginal Bleeding

Do Not Combine

Bacterial Vaginosis

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Gonorrhea

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Levonorgestrel may interact with Pulse Frequency

There are 20 known major drug interactions with Climara Pro.

Common Climara Pro Drug Interactions

Drug Name

Risk Level

Description

Astemizole

Major

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

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Levonorgestrel.

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Levonorgestrel.

Copanlisib

Major

The metabolism of Copanlisib can be decreased when combined with Levonorgestrel.

Crizotinib

Major

The metabolism of Crizotinib can be decreased when combined with Levonorgestrel.

Climara Pro Toxicity & Overdose Risk

In rats, the highest dose of estradiol without causing harm was 0.003mg/kg per day. The lowest toxic dose in women is 21mg/kg, and the highest toxic dose in rats is 960mg/kg. If someone has an overdose of estradiol, they may experience nausea, vomiting, abdominal pain, breast tenderness, blood clots, and vaginal bleeding. Treatment for estradiol overdose includes discontinuing the medication and providing supportive care.

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

Climara Pro Novel Uses: Which Conditions Have a Clinical Trial Featuring Climara Pro?

867 active trials are currently being conducted to assess the efficacy of Climara Pro in treating Osteoporosis, Secondary Amenorrhea and Urogenital Atrophy.

Condition

Clinical Trials

Trial Phases

Endometriosis

28 Actively Recruiting

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

Hot flashes

31 Actively Recruiting

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

Menorrhagia

0 Actively Recruiting

Has had at least 1 child

0 Actively Recruiting

Endometrial Hyperplasia

3 Actively Recruiting

Not Applicable, Phase 2

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Menopause

0 Actively Recruiting

Osteoporosis, Postmenopausal

0 Actively Recruiting

Emergency Contraception

1 Actively Recruiting

Phase 4

Climara Pro Reviews: What are patients saying about Climara Pro?

5

Patient Review

8/18/2022

Climara Pro for "Change of Life" Signs

I find the patch very convenient to use. I change it once a week, on what I like to call "Menopause Monday." I haven't experienced any weight gain or loss since starting this treatment, but my brain fog, vaginal dryness, and sweats have all improved. I generally feel like my old self again with more energy.

5

Patient Review

3/8/2022

Climara Pro for "Change of Life" Signs

I started seeing results within a week, and they just kept getting better and better. I did experience some light vaginal bleeding at the five-week mark, but my doctor says that's normal and nothing to worry about.

4.3

Patient Review

12/7/2018

Climara Pro for "Change of Life" Signs

I had good results from this patch, but after a few months of use I started to experience some skin irritation. I'm hoping there's a milder solution out there that can give me the same peace and calm without the side effects.

4

Patient Review

7/22/2018

Climara Pro for "Change of Life" Signs

This medication has been working great for me and has helped to lessen my bipolar II symptoms. I haven't experienced any negative side effects, which is amazing. Additionally, I found that keeping the patches away from heat seems to help with attachment problems.

3.7

Patient Review

8/8/2019

Climara Pro for "Change of Life" Signs

I started using Climara Pro to mitigate my menopause symptoms, which it did to some extent. However, I have been experiencing vaginal bleeding for the past two months. My doctor says everything looks okay, but I really wish the bleeding would stop. Additionally, the patch could use more adhesive; it often falls off during hot summer months.

3

Patient Review

5/28/2018

Climara Pro for Post-Menopausal Osteoporosis Prevention

It's really frustrating how hard it is to peel the backing off these patches. I've wasted so many because of it. That said, my bone density reports have been good since starting this medication, so I guess it's a love-hate relationship.

3

Patient Review

4/22/2022

Climara Pro for "Change of Life" Signs

While this treatment was initially effective in managing my mood swings and hot flashes, I began to experience uncontrollable hunger which led to rapid weight gain. Consequently, I had to stop using the patch.

2.7

Patient Review

5/23/2022

Climara Pro for "Change of Life" Signs

I found this product effective for menopause symptoms like hot flashes and body aches. However, I stopped using it after 8 months because I felt like it was making me forgetful. According to my research, early dementia is a side effect of this medication—and that's something I'd rather avoid in exchange for the hot flashes.

2.3

Patient Review

3/1/2021

Climara Pro for "Change of Life" Signs

Out of the three boxes I received, only one had patches that actually worked. And even then, it killed my sex drive. So while it did help with hot flashes, I can't in good faith recommend this product.

1.7

Patient Review

10/31/2022

Climara Pro for "Change of Life" Signs

The side effects of this medication were extremely unpleasant. I experienced hot, swollen hands and feet; headaches; weight gain; vaginal discharge; heart palpitations; breathlessness; itchy calves; total loss of libido; food cravings; blurred vision; and cramping. I was very glad to be done with the treatment after just four days.

1

Patient Review

8/14/2019

Climara Pro for "Change of Life" Signs

The Climara Pro patch was a terrible experience for me. After just three days, the patch started coming off. By day four, it was almost completely gone and formed cone-shaped openings. I would not recommend this patch to anyone.

1

Patient Review

6/1/2020

Climara Pro for "Change of Life" Signs

This patch is ridiculously expensive and it doesn't even stay on.

1

Patient Review

3/27/2020

Climara Pro for "Change of Life" Signs

I found this patch to be ineffective as it did not stay on for the entire week. I would suggest that the manufacturers consider making a daily patch.

1

Patient Review

10/17/2022

Climara Pro for "Change of Life" Signs

This patch is terrible. It's cheaply made, falls off constantly, and is a general waste of money. Do not bother buying this product.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about climara pro

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

How long does it take for Climara Pro patch to work?

"I was prescribed Climara Pro and within four days, all my anxiety, hot flashes, and depression disappeared! It was like magic. Sometimes I have spotting or bleeding for a few days, but I'm happy to deal with that."

Answered by AI

What is Climara Pro used for?

"Climara Pro is a medication that contains both an estrogen and a progestogen. It is used to reduce hot flashes and help prevent osteoporosis in postmenopausal women who have a uterus."

Answered by AI

What are the side effects of Climara?

"You may experience skin redness or irritation, abdominal pain, nausea or vomiting, bloating, breast tenderness, headache, or weight changes when taking this medication. If you experience any of these symptoms, speak to your doctor or pharmacist."

Answered by AI

What is the difference between Climara and Climara Pro?

"Climara Pro and Climara are both skin patches. Climara Pro is applied once a week and Climara is applied once or twice a week."

Answered by AI

Clinical Trials for Climara Pro

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 Alethios in San Francisco, United States.

Fiber Supplement for Endometriosis

18 - 45
Female
San Francisco, CA

This study is a double-blind, randomized, placebo-controlled study that evaluates the safety and tolerability of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks. The primary objective is to evaluate the safety and tolerability of the supplement, measured by the incidence and severity of gastrointestinal adverse events (AEs) and discontinuations. Secondary objectives include assessing the fibers impact on gastrointestinal symptoms and quality of life through the use of custom questionnaires built for the study population and evaluation of other endometriosis related parameters such as pelvic discomfort. Exploratory objectives focus on the exploration of the gut and vaginal microbiomes, their connection to endometriosis, and how they are impacted by the study product.

Recruiting
Paid Trial

Alethios

Bryce Jarman, PhD

Alethios, Inc.

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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We made a collection of clinical trials featuring Climara Pro, we think they might fit your search criteria.
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Image of University of Alberta in Edmonton, Canada.

Pelvic Floor Physical Therapy for Endometriosis

18 - 50
Female
Edmonton, Canada

Endometriosis is a chronic inflammatory condition where there is abnormal tissue growing in the pelvis or other places in the body that resembles the lining of the uterus (endometrium), and is a common cause of long lasting pelvic pain. Surgery is sometimes done for endometriosis to help people with pain, however it is common for people to have some pain after surgery that doesn't go away. This may be related to other painful things like muscle pain in the pelvis, bowel or bladder issues, or mental health conditions. Researchers would like to know if doing pelvic floor physiotherapy before surgery for endometriosis will help people with long lasting pain after surgery. Participants in the study will be randomly put into one of two groups: the intervention group, who will receive two to three structured in-person pelvic floor physiotherapy sessions prior to surgery ("prehabilitation"), in addition to usual surgical care, or the control group, who will receive usual surgical care, and may still access physiotherapy outside of the study if they want to. All participants will complete questionnaires before surgery, after completing prehabilitation or immediately before surgery if they are part of the control group, approximately 6 weeks after surgery, 6 months after surgery, and 12 months after surgery. The questionnaires ask about endometriosis-related pain, quality of life, bladder and bowel symptoms, and mental well-being.

Waitlist Available
Has No Placebo

University of Alberta

Alicia Long, MD, MSc, FRCSC

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

Image of UConn Health in Farmington, United States.

Educational Videos for Pre-operative Anxiety

18+
Female
Farmington, CT

The goal of this clinical trial is to learn if educational videos can reduce pre-operative anxiety in patients undergoing minimally invasive gynecologic surgery. The main question it aims to answer are: do patient education videos decrease preoperative anxiety? do patient education videos increase patient preparedness for surgery? Researchers will compare the group who watched the videos preoperatively to the group who only underwent the usual counseling at the preoperative visit to see if the results of a survey that measures anxiety and preparedness differ. Participants will be randomly assigned to one of two groups: one group that will be asked to watch the educational videos and one group that will not. All participants will attend their pre-operative appointment as usual and complete a survey afterwards.

Waitlist Available
Has No Placebo

UConn Health

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