Kyleena

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more
Treatment
7 FDA approvals
20 Active Studies for Kyleena

What is Kyleena

LevonorgestrelThe Generic name of this drug
Treatment SummaryLevonorgestrel (LNG) is a synthetic hormone used in contraception and hormone therapy. It is also known as Plan B and is most commonly used in emergency contraception. It can also be found in intrauterine devices (IUDs) such as Jaydess, Kyleena, and Mirena, as well as in a long-term subdermal implant. Levonorgestrel was approved by the FDA in 1982 and is known for its high levels of efficacy and lack of estrogenic side effects. It is the most widely used emergency contraceptive around the world.
Triphasil-21is the brand name
image of different drug pills on a surface
Kyleena 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 Postmenopausal Osteoporosis .
Osteoporosis, Postmenopausal
Used to treat Postmenopausal Osteoporosis 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
Hot flashes
Used to treat Menopause in combination with Estradiol

Effectiveness

How Kyleena Affects PatientsLevonorgestrel is a hormone that prevents pregnancy by stopping ovulation, fertilization, and implantation. If taken correctly within 72 hours of intercourse, it is 89% effective as an emergency contraceptive. When used as part of a hormonal therapy, levonorgestrel can also help prevent endometrial cancer. Intrauterine and implantable devices containing levonorgestrel are more than 99% effective in preventing pregnancy.
How Kyleena works in the bodyLevonorgestrel works to prevent pregnancy in several ways. It blocks the release of hormones that trigger ovulation, making it harder for a viable egg to be released from the ovaries. It also thickens the cervical mucus and changes the endometrium, making it harder for sperm to reach the egg and for a fertilized egg to implant. Finally, when combined with estrogen, it reduces the risk of endometrial cancer.

When to interrupt dosage

The recommended dosage of Kyleena is contingent upon the diagnosed condition, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The measure of dosage is decided by the mode of administration outlined in the table underneath.
Condition
Dosage
Administration
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Implant, Implant - Subcutaneous, Insert, extended release - Intrauterine, Insert, extended release, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Implant, Implant - Subcutaneous, Insert, extended release - Intrauterine, Insert, extended release, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Implant, Implant - Subcutaneous, Insert, extended release - Intrauterine, Insert, extended release, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Implant, Implant - Subcutaneous, Insert, extended release - Intrauterine, Insert, extended release, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Implant, Implant - Subcutaneous, Insert, extended release - Intrauterine, Insert, extended release, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Implant, Implant - Subcutaneous, Insert, extended release - Intrauterine, Insert, extended release, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Implant, Implant - Subcutaneous, Insert, extended release - Intrauterine, Insert, extended release, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Implant, Implant - Subcutaneous, Insert, extended release - Intrauterine, Insert, extended release, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous
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, Tablet - Oral, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Implant, Implant - Subcutaneous, Insert, extended release - Intrauterine, Insert, extended release, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous

Warnings

Kyleena Contraindications
Condition
Risk Level
Notes
Severe Hypersensitivity Reactions
Do Not Combine
Levonorgestrel may interact with Pulse Frequency
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
There are 20 known major drug interactions with Kyleena.
Common Kyleena 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.
Kyleena Toxicity & Overdose RiskThe lowest toxic dose of levonorgestrel in rats is greater than 5000mg/kg. Those who overdose on the drug can experience nausea and bleeding. Treatment for an overdose includes symptom relief and contacting a poison control center. There is no specific antidote for levonorgestrel overdose.
image of a doctor in a lab doing drug, clinical research

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

99 active clinical trials are currently being conducted to assess the potential of Kyleena to address Postmenopausal Osteoporosis, Women who have had at least one child, and Endometrial Hyperplasia.
Condition
Clinical Trials
Trial Phases
Endometriosis
27 Actively Recruiting
Early Phase 1, Phase 2, Not Applicable, Phase 3, Phase 4
Hot flashes
19 Actively Recruiting
Not Applicable, Phase 4, Phase 2, Early Phase 1, Phase 3
Menorrhagia
3 Actively Recruiting
Phase 1, Phase 2, Not Applicable
Has had at least 1 child
0 Actively Recruiting
Endometrial Hyperplasia
4 Actively Recruiting
Not Applicable, Phase 2, Phase 3
moderate Menopausal Vasomotor Symptoms
0 Actively Recruiting
Menopause
0 Actively Recruiting
Osteoporosis, Postmenopausal
0 Actively Recruiting
Emergency Contraception
1 Actively Recruiting
Phase 4

Kyleena Reviews: What are patients saying about Kyleena?

1.7Patient Review
6/3/2020
Kyleena for Birth Control
DO NOT GET THIS IUD IF YOU HAVE ANY KIND OF ACNE PROBLEMS. It made my acne SO much worse and it never went away. My whole body is covered in dark scars now, six months after having the IUD removed.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about kyleena

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

How is Kyleena different than Mirena?

"An IUD, or intrauterine device, is a form of contraception that is placed in the uterus by a healthcare professional. It can prevent pregnancy for up to 5 or 7 years, depending on the type."

Answered by AI

Does Kyleena stop periods?

"Your periods may become shorter and lighter over time, or they may stop entirely. If Kyleena is removed, your periods should return. Approximately 12 out of 100 women stop having periods after 1 year of Kyleena use. If you do not have a period for 6 weeks during Kyleena use, call your healthcare professional."

Answered by AI

Does Kyleena cause weight gain?

"Kyleena can cause weight gain in some women, even though it's not a common side effect. Most likely, the weight gain is from water retention caused by the progestin in Kyleena, not from an increase in body fat."

Answered by AI

Is Kyleena 3 or 5 years?

"If you want to use Kyleena for more than 5 years, you will need to replace the system after 5 years."

Answered by AI

Clinical Trials for Kyleena

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
Image of University Hospitals Cleveland Medical Center in Cleveland, United States.

Ketamine for Pelvic Pain

18 - 89
Female
Cleveland, OH
The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA. Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.
Phase 4
Waitlist Available
University Hospitals Cleveland Medical CenterMorgan Cheeks, MD
Have you considered Kyleena clinical trials? We made a collection of clinical trials featuring Kyleena, we think they might fit your search criteria.Go to Trials
Image of William J. Hybl Sports Medicine and Performance Center in Colorado Springs, United States.

Moderate Aerobic Exercise for Menstrual Symptoms

18 - 40
Female
Colorado Springs, CO
The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are: Is there a reduction in physical and/or psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives? Is there a difference in physical and/or psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users? Is a moderate aerobic exercise intervention more effective in reducing physical and/or psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives? Participants will: * Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention. * Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly. * Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length. * Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly. * Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles.
Recruiting
Has No Placebo
William J. Hybl Sports Medicine and Performance Center
Have you considered Kyleena clinical trials? We made a collection of clinical trials featuring Kyleena, we think they might fit your search criteria.Go to Trials
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NettleEndo for Endometriosis

22 - 45
Female
San Francisco, CA
The goal of this clinical trial is to learn if a wearable brain stimulation device called NettleEndo can reduce chronic pelvic pain and improve wellbeing in women with endometriosis. The study also aims to assess the safety and usability of the device when used at home over several months. The main questions it aims to answer are: 1. Does at-home transcranial direct current stimulation (tDCS) reduce daily pain intensity in women with endometriosis? 2. Does the device also improve mood and sleep quality? Researchers will compare two groups-one receiving active brain stimulation and one receiving a sham (placebo) stimulation-to see if the active device provides greater improvements in symptoms. Participants will: 1. Use the NettleEndo device at home for 20 minutes per session, five times per week for 12 weeks 2. Be randomly assigned to receive either real or sham stimulation through the device 3. Complete daily and weekly symptom ratings through a mobile app 4. Wear an optional fitness tracker to collect data on sleep, movement, and heart rate variability 5. Be followed for 60 days after completing the intervention to monitor longer-term effects All activities are completed remotely using a smartphone app. Participants can contact the study team with questions at any time. The study is double-blind, meaning neither participants nor the researchers assessing outcomes will know who received active or sham treatment until the end of the trial.
Recruiting
Online Trial
Alethios, Inc.Nirav Shah, MD, MPHSamphire Group, Inc.
Image of University of Alabama at Birmingham in Birmingham, United States.

Mirena for Endometrial Hyperplasia

18+
Female
Birmingham, AL
Researchers are looking for a better way to treat women with nonatypical endometrial hyperplasia (NAEH). Endometrial hyperplasia is a condition where the lining of the uterus (called the endometrium) becomes too thick. Nonatypical means that the condition is not cancerous. It is often caused by hormone imbalances in women. Symptoms can include abnormal vaginal bleeding or irregular periods. If this condition is not treated, then it may lead to cancer. Currently, there are no approved treatments for NAEH and that is why there is still an unmet medical need. The study treatment, Mirena (also known as BAY 865028), is already available as a type of birth control device. It is inserted into the uterus where it gradually releases progesterone. In this study, researchers want to find out if Mirena works for women with NAEH. They believe it can help by keeping hormone levels balanced in the body. The main purpose of this study is to show that uterine lining goes back to completely normal lining after treatment with Mirena and that its use is safe in this population. For this, the researchers will compare the number of participants with benign endometrium after 6 months of treatment with Mirena or oral MPA. The study participants will be randomly assigned into one of two treatment groups. The randomization will be done 2:1 ratio, meaning that for every two participants assigned to Mirena, one will be assigned to oral medroxyprogesterone acetate (MPA). Based on their group, participants will receive Mirena, which is inserted into the uterus at the start of the study, or they will take progestins once daily by mouth for 6 months. Each participant will be in the study for around 10 months with up to 5 visits to the study clinic/site. Participants will visit the study clinic: * once before the treatment starts * 3 times with a gap of 3 months between the visits during the treatment * then 1 more time after the treatment ends During the study, the doctors and their study team will: * check participant's health by performing tests such as blood and urine tests * perform vaginal ultrasound and hysteroscopy. Hysteroscopy is a minor surgical procedure where a thin camera will be inserted into the womb to check for any abnormality. Sampling of the endometrial lining (cells in the womb) will be done with a thin tube at the same time. * take samples of womb (endometrial) lining * ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Phase 3
Recruiting
University of Alabama at Birmingham (+78 Sites)Bayer
Image of Baylor College of Medicine in Hosuton, United States.

Dronabinol for Endometriosis

18 - 64
Female
Hosuton, TX
This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for e endometriosis-associated chronic pelvic pain (endo-CPP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.
Phase 2
Waitlist Available
Baylor College of Medicine (+1 Sites)Christopher Verrico, PhD in Pharmacology
Have you considered Kyleena clinical trials? We made a collection of clinical trials featuring Kyleena, we think they might fit your search criteria.Go to Trials
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