Simpesse

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more

Treatment

7 FDA approvals

20 Active Studies for Simpesse

What is Simpesse

Levonorgestrel

The Generic name of this drug

Treatment Summary

Levonorgestrel (LNG) is a hormone medication used in contraception and hormone therapy. It is commonly known as Plan B and can be taken as a single pill for emergency contraception or as an IUD (also known as Jaydess, Kyleena, and Mirena). It can also be used in combination with other contraceptives or in an implant form which is inserted under the skin and slowly releases the hormone over a long-term period. Levonorgestrel is the most widely used emergency contraceptive worldwide and was the first to be approved by the FDA in 1982 due to its high efficacy and low levels of estrogenic

Triphasil-21

is the brand name

Simpesse 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 Simpesse Affects Patients

Levonorgestrel can help prevent pregnancy by stopping ovulation, fertilization, and implantation. If taken as a tablet within 72 hours of intercourse, it is 89% effective. If used as an intrauterine or implantable device, it is over 99% effective. Levonorgestrel can also be used as part of hormonal therapy to help prevent endometrial cancer caused by unopposed estrogen.

How Simpesse works in the body

Levonorgestrel is used in oral contraceptives to prevent ovulation. It does this by slowing down the release of hormones that trigger ovulation. It also increases the thickness of cervical mucus, which stops sperm from entering the uterus. Over a long-term period, levonorgestrel has been shown to thicken cervical mucus. The exact way it works is not completely understood. When used in combination with estrogen for menopausal symptoms and osteoporosis, levonorgestrel helps reduce the risk of endometrial cancer. It does this by inhibiting the growth of the endometrium.

When to interrupt dosage

The proposed dosage of Simpesse is dependent upon the determined condition, like Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The magnitude of dosage fluctuates, based on the administration approach noted 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, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

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

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

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

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

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

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

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

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

Warnings

Simpesse 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 Simpesse.

Common Simpesse 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.

Simpesse Toxicity & Overdose Risk

The lowest toxic dose of levonorgestrel in rats is greater than 5000 mg/kg. If someone overdoses on levonorgestrel, they may experience nausea and bleeding. Treat the symptoms and contact poison control for help. There is no known antidote for a levonorgestrel overdose.

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

99 active clinical trials are currently underway, assessing the potential of Simpesse to address Postmenopausal Osteoporosis, Past Childbearing and Endometrial Hyperplasia.

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

Simpesse Reviews: What are patients saying about Simpesse?

1

Patient Review

12/24/2021

Simpesse for Birth Control

I didn't have my normal brand of birth control, so I was given this one instead. Unfortunately, it seems like these pills were ineffective; I started my period as soon as I began taking them
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about simpesse

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

Is Simpesse the same as seasonique?

"The drugs Seasonique, Amethia, Camrese, Daysee, Simpesse, Ashlyna, and Jaimiess all have the same active ingredient and dosage. Seasonale, Introvale, Jolessa, and Quasense also have the same active ingredient and dosage."

Answered by AI

What is Simpesse used for?

"The combination hormone medication contains a progestin and an estrogen to prevent pregnancy."

Answered by AI

What kind of birth control is Simpesse?

"Simpesse is a 84-day extended-cycle oral contraceptive that contains low-dose levonorgestrel and ethinyl estradiol. The pills are taken daily for 12 weeks, followed by a one-week break."

Answered by AI

Clinical Trials for Simpesse

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
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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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

Image of Icahn School of Medicine at Mount Sinai in New York, United States.

Personalized Exercise for Chronic Pelvic Pain

18 - 55
Female
New York, NY

WorkoutCPP is a pilot study evaluating the feasibility of a personalized exercise recommendation system for individuals with chronic pelvic pain disorders (CPPDs). The study uses reinforcement learning (RL), a type of artificial intelligence that adapts recommendations over time based on each participant's reported pain levels, symptom burden, and exercise compliance. Participants receive daily exercise recommendations that alternate between standard, non-personalized guidance and personalized, RL-generated recommendations across four 2-week phases, allowing within-person comparison of outcomes under each condition. The primary hypothesis is that an RL-based adaptive recommendation system is feasible to deliver in a CPPD population.

Recruiting
Has No Placebo

Icahn School of Medicine at Mount Sinai

Ipek Ensari, PhD

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