Norplant

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more

Treatment

7 FDA approvals

20 Active Studies for Norplant

What is Norplant

Levonorgestrel

The Generic name of this drug

Treatment Summary

Levonorgestrel (LNG) is a synthetic progestogen hormone used for contraception and hormone therapy. It is often sold under the brand name Plan B and is used as an emergency contraceptive pill or in an intrauterine device (IUD) such as Jaydess, Kyleena, or Mirena. It can also be used in a subdermal implant to provide long-term contraception. Levonorgestrel was first approved by the FDA in 1982 and is one of the most widely used emergency contraceptives due to its high levels of efficacy and lack of estrogenic side effects compared to other emergency contraceptive regimens

Triphasil-21

is the brand name

Norplant 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 Norplant Affects Patients

Levonorgestrel is used as an emergency contraceptive to prevent pregnancy. It works by preventing ovulation, fertilization, and implantation. If used within 72 hours after intercourse, the levonorgestrel-only pill is 89% effective. Higher levels of effectiveness (over 99%) are achieved when using intrauterine or implantable devices that release levonorgestrel. Additionally, levonorgestrel is used in combination with estrogen to help protect against endometrial cancer.

How Norplant works in the body

Levonorgestrel is an oral contraceptive and hormone therapy that works to prevent pregnancy. It stops ovulation by slowing the release of hormones from the hypothalamus. It also thickens cervical mucus so that sperm cannot reach the egg, and can cause changes to the endometrium, making it harder for a fertilized egg to implant. For hormone therapy, levonorgestrel works with estrogen to reduce the risk of endometrial cancer.

When to interrupt dosage

The endorsed measure of Norplant is dependent upon the established condition, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The sum of dosage fluctuates, according to the administration procedure outlined 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, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, 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 - Oral, Tablet, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, 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 - Oral, Tablet, Intrauterine, Intrauterine device, Intrauterine device - Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated, Subcutaneous

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

Warnings

Norplant has forty-three contraindications and must not be taken if you are experiencing any of the states indicated in the following table.

Norplant 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 Norplant.

Common Norplant 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.

Norplant Toxicity & Overdose Risk

The lowest toxic dose of levonorgestrel in rats has been found to be greater than 5000 mg/kg. Signs of an overdose may include nausea and bleeding, and should be treated with supportive care. There is currently no antidote for a levonorgestrel overdose.

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

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

99 active trials are presently researching the potential of Norplant to treat Postmenopausal Osteoporosis, Individuals who have had at least one child and Endometrial Hyperplasia.

Condition

Clinical Trials

Trial Phases

Endometriosis

29 Actively Recruiting

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

Hot flashes

30 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

Norplant Reviews: What are patients saying about Norplant?

4.7

Patient Review

6/1/2016

Norplant for Birth Control

I had the implant for five years and it was a very easy procedure to remove. I did experience irregular cycles and lots of spotting, but otherwise I had no ill side effects. The only downside is that it can cause irregular periods, but other than that I would recommend this to anyone looking for long-term birth control.

4.3

Patient Review

9/16/2015

Norplant for Birth Control

I only gained about five pounds in weight, which was the only side effect I experienced. I had three separate Norplants over the course of five years. In my opinion, this is the best form of birth control and I'm disappointed it's not an option for my daughters.

3.7

Patient Review

8/3/2012

Norplant for Birth Control

I had the Norplant for six years and then got it removed. I later decided to get it implanted again and have been very pleased with it overall. I haven't experienced any negative side effects.

3.7

Patient Review

8/12/2013

Norplant for Birth Control

I had this product inserted when I was 20 and removed it about six months later. Unfortunately, I nearly went blind as a result and ended up in the emergency room on Christmas Eve in 1992. The doctor who removed it swore he would never remove another one; it took him almost three hours to get it out. Consequently, I have a large scar on my arm from where he had to dig it out. All things considered, I would not recommend this product to anyone.

3.7

Patient Review

2/20/2009

Norplant for Birth Control

2.7

Patient Review

7/7/2010

Norplant for Birth Control

I had the Norplant contraceptive implanted after the birth of my child at 15. I experienced a lot of symptoms and had it removed within a year. 16 years later, I'm still dealing with abdominal discomfort, headaches, visual disturbance, severe depression and anxiety, mood swings, and many other issues. I feel like Norplant is to blame for my current condition and I would not recommend it to anyone.

2.3

Patient Review

4/22/2009

Norplant for Birth Control

1.7

Patient Review

3/14/2011

Norplant for Birth Control

I had the norplant put in after my son was born. I wanted to wait a few years before having more kids. I had it put in in 1999 and had it removed in 2004. After that I tried getting pregnant and was unable to. The dr. said it had nothing to do with the norplant, but after 5 years of trying I finally gave up on getting pregnant.

1

Patient Review

9/24/2009

Norplant for Birth Control

I had this treatment for three months and it was terrible. I gained thirty pounds, grew a beard, and then had to get it removed. I've been shaving ever since. I wouldn't even give this to my dog.

1

Patient Review

10/5/2012

Norplant for Birth Control

I regret taking this drug. I'm having it removed due to feeling constantly ill; including weight gain, aches all over my body, headaches every day, an upset stomach, and fluid retention. These are only some of the issues I've had since starting this medication.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about norplant

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

Clinical Trials for Norplant

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
New This Month

MusB Research LLC

Vidya USA Corporation

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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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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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