Setlakin

Birth Control, Acne Vulgaris, Folate supplementation therapy + 5 more

Treatment

1 FDA approval

20 Active Studies for Setlakin

What is Setlakin

Ethinylestradiol

The Generic name of this drug

Treatment Summary

Levonorgestrel is a type of synthetic hormone used in contraception and hormone therapy. It is known by the brand name Plan B and is used as a single agent in emergency contraception or released from an intrauterine device. Levonorgestrel is also available as a long-term subdermal implant and is used in combination contraceptives. FDA approved in 1982, levonorgestrel is the most commonly used emergency contraceptive worldwide as it is highly effective and has few estrogenic side effects.

LOESTRIN Fe 1.5/30

is the brand name

image of different drug pills on a surface

Setlakin Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

LOESTRIN Fe 1.5/30

Ethinylestradiol

1973

679

Approved as Treatment by the FDA

Ethinylestradiol, also known as LOESTRIN Fe 1.5/30, is approved by the FDA for 1 uses including Birth Control .

Birth Control

Used to treat Contraception in combination with Levonorgestrel

Effectiveness

How Setlakin Affects Patients

Levonorgestrel can be used as an emergency contraceptive to prevent pregnancy up to 72 hours after intercourse. It works by stopping ovulation, fertilization, and implantation. It is 89% effective when taken correctly. Levonorgestrel can also be used in intrauterine and implantable devices, which are more than 99% effective in preventing pregnancy. Finally, it is sometimes used as part of hormone therapy to lower the risk of endometrial carcinoma caused by estrogen.

How Setlakin works in the body

Levonorgestrel works to prevent pregnancy in several ways. It suppresses the release of hormones that trigger ovulation, preventing an egg from being released from the ovary. It also thickens cervical mucus, making it harder for sperm to enter the uterus and fertilize the egg. Finally, it causes changes in the endometrium which can make it harder for a fertilized egg to implant. In addition to its contraceptive effects, levonorgestrel can be used in combination with other hormones to reduce the risk of endometrial cancer in women taking estrogen therapy.

When to interrupt dosage

The measure of Setlakin depends upon the diagnosed state, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The amount of dosage is contingent upon the approach of administration noted in the table underneath.

Condition

Dosage

Administration

Birth Control

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule - Oral, Capsule

Folate supplementation therapy

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Hormonal Contraception

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Menopause

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Acne Vulgaris

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Patient desires oral contraception for birth control

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Acne Vulgaris

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Osteoporosis

, 0.02 mg, 0.0025 mg, 0.03 mg, 0.0035 mg/hour, 0.005 mg, 2.7 mg, 0.035 mg, 0.6 mg, 2.6 mg, 0.05 mg, 0.5 mg, 0.75 mg, 0.025 mg, 0.0015 mg/hour, 0.04 mg, 0.01 mg, 1.0 mg, 0.075 mg, 0.105 mg, 0.07 mg, 0.1 mg, 0.75 mg/[USP'U], 0.0075 mg/hour, 17.4 mg, 0.085 mg, 2.3 mg

, Kit, Tablet - Oral, Oral, Tablet, Kit - Oral, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Insert, extended release, Vaginal, Insert, extended release - Vaginal, Ring - Vaginal, Ring, Tablet, chewable, Tablet, chewable - Oral, Tablet, film coated, Tablet, film coated - Oral, Patch, Patch - Transdermal, Capsule, Capsule - Oral

Warnings

Setlakin has forty-three contraindications and should not be employed when encountering any of the conditions detailed in the following table.

Setlakin Contraindications

Condition

Risk Level

Notes

Smoking

Do Not Combine

Metrorrhagia

Do Not Combine

estrogen-sensitive cancer

Do Not Combine

Thrombophlebitis

Do Not Combine

Venous Thrombosis

Do Not Combine

Venous Thrombosis

Do Not Combine

Pulse Frequency

Do Not Combine

Breast

Do Not Combine

Coronary Artery Disease

Do Not Combine

high risk of arterial thrombotic disease

Do Not Combine

Thromboembolism

Do Not Combine

Coronary Disease

Do Not Combine

Hypersensitivity

Do Not Combine

Pulse Frequency

Do Not Combine

Adrenal Insufficiency

Do Not Combine

major surgery with prolonged immobilization

Do Not Combine

Pulse Frequency

Do Not Combine

Hypertension

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Breast Cancer

Do Not Combine

Liver Neoplasms

Do Not Combine

Deep Vein Thrombosis

Do Not Combine

Fibrosis

Do Not Combine

Breast

Do Not Combine

Renal Insufficiency

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Ethinylestradiol may interact with Pulse Frequency

There are 20 known major drug interactions with Setlakin.

Common Setlakin Drug Interactions

Drug Name

Risk Level

Description

Anastrozole

Major

The therapeutic efficacy of Anastrozole can be decreased when used in combination with Ethinylestradiol.

Astemizole

Major

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

Axitinib

Major

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

Belinostat

Major

The metabolism of Belinostat can be increased when combined with Ethinylestradiol.

Binimetinib

Major

The metabolism of Binimetinib can be increased when combined with Ethinylestradiol.

Setlakin Toxicity & Overdose Risk

The lowest dose of levonorgestrel that is toxic to rats is greater than 5000mg/kg. Symptoms of an overdose may include nausea and bleeding, and there is no specific antidote. If someone has overdosed on levonorgestrel, they should receive supportive care and contact their local poison control center.

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

99 active studies are currently analyzing the potential of Setlakin in treating Postmenopausal Osteoporosis, Women Who Have Had at Least One Child and Endometrial Hyperplasia.

Condition

Clinical Trials

Trial Phases

Birth Control

21 Actively Recruiting

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

Hormonal Contraception

0 Actively Recruiting

Folate supplementation therapy

0 Actively Recruiting

Patient desires oral contraception for birth control

0 Actively Recruiting

Osteoporosis

0 Actively Recruiting

Acne Vulgaris

0 Actively Recruiting

Acne Vulgaris

0 Actively Recruiting

Menopause

0 Actively Recruiting

Setlakin Reviews: What are patients saying about Setlakin?

3.3

Patient Review

1/10/2018

Setlakin for Birth Control

I've been experiencing unusual and heavy bleeding for the past five months. I'm not sure if this is due to the birth control or not, but it's otherwise a great medication with no weight gain or skin problems.

2.7

Patient Review

4/23/2017

Setlakin for Painful Periods

The neuromuscular pain I've been experiencing in my back, hips and shoulders is really bad. It's only been a week and I'm already considering switching to a different generic brand. The over the counter NSAIDS I'm taking for relief aren't doing enough. At this point, I might even prefer having painful periods again.

2.3

Patient Review

8/6/2016

Setlakin for Painful Periods

I was on Jolessa for years, but my pharmacy switched me to Setlakin. I've been bleeding for over 70 days now since my last period. I had an ultrasound--no fibroids or cysts. Think it might be the Setlakin

Patient Q&A Section about setlakin

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

When should I start taking Setlakin?

"For each 91-day course, take the first pink tablet on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day."

Answered by AI

What are the side effects of Setlakin?

"You may experience some side effects while taking this medication, such as nausea, vomiting, headaches, bloating, breast tenderness, swelling of the ankles or feet (fluid retention), or weight change. Some women also experience vaginal bleeding between periods (spotting), especially during the first few months of use."

Answered by AI

What kind of pill is Setlakin?

"SetlakinTM is an extended-cycle combination oral contraceptive that consists of 84 pink active tablets. Each tablet contains 0.15 mg of levonorgestrel, a synthetic progestin, and 0.03 mg of ethinyl estradiol, an estrogen. There are also 7 white inert tablets (without hormones) in the combination."

Answered by AI

What is Setlakin generic for?

"Introvale and Setlakin are both generic and brand versions of the same birth control pill. They contain the same active ingredients in the same doses, so they will work the same way when taken as directed."

Answered by AI

Clinical Trials for Setlakin

Image of University of California, San Diego in La Jolla, United States.

Lidocaine for Pain Control in Birth Control

18 - 50
Female
La Jolla, CA

The goal of this research study is to learn more about how different uses of a numbing medication might affect pain levels while getting an IUD placed. The investigators are also studying participants opinions of their clinicians' empathy. The investigators are inviting patients who arrive at their clinic visit seeking an IUD. Usually, at University of California, San Diego (UCSD), for patients who have never delivered a baby, clinicians use a buffered paracervical block for before IUD placement. The purpose of this research study is to investigate whether a "buffered" (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block (numbing medication given on both sides of the cervix) is effective in reducing pain during IUD placement in individuals with prior C-sections, the difference between buffered and unbuffered for nulliparous patients, and whether a medicated gel reduces pain with the paracervical block.

Recruiting
Paid Trial

University of California, San Diego

Sheila K Mody, MD, MPH

Image of EmpoweRx, Inc in Del Mar, United States.

HAPPI Software for Birth Control Access

18+
All Sexes
Del Mar, CA

The goal of this clinical trial is to learn if use of the HAPPI software can improve pharmacist-provided birth control services. The main questions it aims to answer are: 1. Does the HAPPI software make it easier for pharmacists to provide birth control services in their pharmacy? 2. Does the HAPPI software make it easier for patients to access birth control? Researchers will compare pharmacists' implementation and patients' access when using the HAPPI software and when not using the HAPPI software to see if the software improves implementation and access. Participants will include pharmacists and patients. Pharmacists will be asked to provide birth control services as normal while using the HAPPI software. Patients will be asked to receive birth control services from a pharmacist as normal, while using the HAPPI software.

Recruiting
Has No Placebo

EmpoweRx, Inc

Image of Calabasas Pharmacy in Calabasas, United States.

Electronic Health Record Platform for Birth Control

18 - 51
Female
Calabasas, CA

Hormonal contraceptives are medications that require a prescription, traditionally from a physician or advanced practice provider. Over the past decade, pharmacists have gained the authority to prescribe contraceptives in many states, allowing patients to access these medications directly in pharmacies without first seeing another healthcare provider. The Pharmacist Resource to Implement Services as Modules (PRISM) is an Electronic Health Record platform designed to streamline workflows and provide clinical decision support, making it easier and safer to deliver clinical services in community pharmacies. This pilot study will evaluate patient-reported outcomes for women receiving contraceptive services from pharmacists using the PRISM platform at five community pharmacies across the United States over a 12-week period. The study will assess the quality of care, contraception continuation and failure rates, side effect rates, preventative healthcare utilization, and overall patient experience with pharmacy contraceptive services.

Waitlist Available
Has No Placebo

Calabasas Pharmacy (+4 Sites)

OvaryIt, LLC

Have you considered Setlakin clinical trials?

We made a collection of clinical trials featuring Setlakin, we think they might fit your search criteria.
Go to Trials
Image of Jackson State University/Department of Behavioral & Environmental Health in Jackson, United States.

PEN-3 Intervention for Postpartum Depression

18 - 45
Female
Jackson, MS

Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.

Recruiting
Has No Placebo

Jackson State University/Department of Behavioral & Environmental Health

Mary Shaw, PhD

Image of University of Colorado Anschutz Medical Campus in Aurora, United States.

Birth Control Pills and DNA Interaction

18 - 45
Female
Aurora, CO

The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how individual bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. The investigators are also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are: * Do individuals with the CYP3A7\*1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill? * Do individuals with the CYP3A7\*1C variant experience higher rates of breakthrough ovulation while taking a desogestrel/ethinyl estradiol combined oral contraceptive pill? * What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users? Participants will take a specific formulation of combined oral contraceptive pill (desogestrel/ethinyl estradiol) and undergo the following procedures: * Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill * Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill * Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill * A transvaginal ultrasound to measure any ovarian follicles (optional procedure)

Phase 4
Recruiting

University of Colorado Anschutz Medical Campus (+2 Sites)

Aaron M Lazorwitz, MD, PhD

Have you considered Setlakin clinical trials?

We made a collection of clinical trials featuring Setlakin, we think they might fit your search criteria.
Go to Trials
Image of Greater Boston Health Center in Boston, United States.

SBIRT for Alcohol and Substance Use Disorders

18+
All Sexes
Boston, MA

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: * Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? * Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? * Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

Recruiting
Has No Placebo

Greater Boston Health Center (+3 Sites)

Kelli S Hall, MD

Image of OHSU in Portland, United States.

Progestin Contraceptives for Birth Control Effects

18 - 40
Female
Portland, OR

The purpose of the study is to learn more about menstrual changes in progestin contraception users. The investigators are hoping to find out what changes in the endometrium lead to different bleeding patterns during the first year of progestin contraception use. Participants will choose to receive the contraceptive implant (Etonogestrel implant also called Nexplanon) or the contraceptive injectable (Depo-medroxyprogesterone acetate (DMPA) also called Depo-Provera) for up to 12 months. They will be asked to have 4 endometrial biopsies over the course of the study, as well as blood draws, physical exams, and pregnancy tests. Participants will also use a daily text message or email diary to report bleeding patterns. This study's plan is to comprehensively phenotype bleeding patterns and profile the entire endometrium using single-cell RNA seq data (sCRNAseq).

Phase < 1
Recruiting

OHSU

Alison Edelman, MD

Have you considered Setlakin clinical trials?

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