Viorele

Birth Control, Hormonal Contraception

Treatment

20 Active Studies for Viorele

What is Viorele

Desogestrel

The Generic name of this drug

Treatment Summary

Desogestrel is a hormone-based drug used to treat reproductive health conditions. It is a synthetic form of the naturally occurring hormones found in plants and was first developed in 1972. Desogestrel is only available in combination with ethinyl estradiol in the US, and was approved by the FDA in 1992.

Desogen

is the brand name

image of different drug pills on a surface

Viorele Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Desogen

Desogestrel

1992

68

Effectiveness

How Viorele Affects Patients

Desogestrel affects many areas of the body, including the reproductive system (it can delay the start of a period, change hormone levels, and make the vaginal fluid thicker), metabolism (increase insulin secretion and resistance, increase lipase activity, and increase fat deposition), and more. It mainly works by stopping ovulation in 97% of cases. Desogestrel has also been linked to an increased risk of blood clotting, but it does not typically have a significant effect on total cholesterol levels.

How Viorele works in the body

Desogestrel works by entering cells and attaching to the progesterone receptor. This switches on certain genes that cause changes in the production of mRNA. The active metabolite of desogestrel, etonogestrel, also has strong progestational activity with very little androgenic effects.

When to interrupt dosage

The proposed dose of Viorele is contingent upon the indicated condition, such as Birth Control, Nursing Women and Hormonal Contraception. The measure of dosage depends upon the technique of administration (e.g. Kit or Kit; Tablet - Oral), as delineated in the table below.

Condition

Dosage

Administration

Birth Control

, 0.15 mg, 0.1 mg, 0.125 mg, 0.375 mg

, Kit, Oral, Tablet - Oral, Tablet, Kit - Oral

Hormonal Contraception

, 0.15 mg, 0.1 mg, 0.125 mg, 0.375 mg

, Kit, Oral, Tablet - Oral, Tablet, Kit - Oral

Warnings

Viorele has twenty-five contraindications and should not be taken in alliance with the disorders indicated in the following table.

Viorele Contraindications

Condition

Risk Level

Notes

Stroke

Do Not Combine

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

Liver Cancer

Do Not Combine

Endometrial Neoplasms

Do Not Combine

Thromboembolism

Do Not Combine

Thromboembolism

Do Not Combine

Major Surgery

Do Not Combine

benign hepatic adenoma

Do Not Combine

Breast Cancer

Do Not Combine

Liver Diseases

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Breast

Do Not Combine

Type 2 Diabetes

Do Not Combine

Coronary Disease

Do Not Combine

Thrombophlebitis

Do Not Combine

Thrombophilia

Do Not Combine

Diastolic blood pressure

Do Not Combine

Hypertension

Do Not Combine

Jaundice, Obstructive

Do Not Combine

Venous Thrombosis

Do Not Combine

Icterus

Do Not Combine

focal neurological symptoms

Do Not Combine

Heart Valve Diseases

Do Not Combine

estrogen-dependent neoplasia

Do Not Combine

There are 20 known major drug interactions with Viorele.

Common Viorele Drug Interactions

Drug Name

Risk Level

Description

Axitinib

Major

The metabolism of Axitinib can be increased when combined with Desogestrel.

Belinostat

Major

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

Binimetinib

Major

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

Enasidenib

Major

The metabolism of Enasidenib can be increased when combined with Desogestrel.

Etoposide

Major

The metabolism of Etoposide can be increased when combined with Desogestrel.

Viorele Toxicity & Overdose Risk

Taking a large amount of desogestrel may cause strong hormonal effects but not long-term harm. In rats, the toxic dose was found to be higher than 2000mg/kg. Overdosing on desogestrel may cause nausea and stop menstruation, but it is not known to increase the risk of breast cancer. Some studies suggest a potential increased risk of cervical intra-epithelial neoplasia, but this has yet to be proven.

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

38 active clinical trials are evaluating the potential of Viorele to provide Nursing Women, Birth Control and Hormonal Contraception for the treatment of certain disorders.

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

Viorele Reviews: What are patients saying about Viorele?

5

Patient Review

4/25/2020

Viorele for Birth Control

I've been on this prescription for over two years and it's never given me any problems. My skin is clear, my hormones are under control, and most importantly- I'm not pregnant. Every drug works differently for different people, but this one works for me. I recommend the pill to all my friends who are looking for contraception. I also skip my periods; the last time I had a period was about five months ago. I love being on the pill!

4.7

Patient Review

8/6/2019

Viorele for Abnormally Long or Heavy Periods

Viorele has been my go-to for a few years now. Prior to taking this medication, my periods were incredibly painful to the point where I would feel nauseous and have heavy bleeding that would last for days on end. Viorele has helped immensely with both cramping and acne, though I have noticed a significant decrease in libido.

2.3

Patient Review

1/15/2019

Viorele for Birth Control

I started taking this medication and saw an unfortunate uptick in the number of pimples, as well as their severity. It was all over my face, painful, and made me very insecure. Additionally, it caused difficulty sleeping and increased moodiness.

2.3

Patient Review

2/28/2020

Viorele for Birth Control

CVS's change from Kariva to Viorele has really messed with my head twice now. I had mood swings and felt depressed both times.

2.3

Patient Review

4/2/2017

Viorele for Birth Control

I've been on this pill for 12 days and have found myself to be much more moody than usual. I'm going back to my old pill immediately.

1

Patient Review

2/22/2018

Viorele for Birth Control

Do not take this medication! I have experienced bloating, nausea, weight/appetite gain (it's been 12 days), extreme rage, breast tenderness and lumps. I have probably gained 5 pounds in less than two weeks.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about viorele

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

What type of birth control is Viorele?

"The Viorele birth control pill contains female hormones that prevent ovulation (the release of an egg from an ovary). Viorele also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus."

Answered by AI

What is Viorele used for?

"This medication, which contains a combination of two hormones (a progestin and an estrogen), is used to prevent pregnancy."

Answered by AI

Does Viorele cause weight gain?

"Can Viorele cause weight gain? Some women worry about this when taking Viorele and other birth control pills. While it might make you feel hungrier, it's mostly water retention (and not actual fat) that's to blame."

Answered by AI

Does Viorele make you depressed?

"I wouldn't recommend it.”

I had a terrible experience with Viorele, and it only took a couple days for the anxiety and depression to set in. It's been just over a week now, and the drug has caused me anxiety attacks and problems in my relationships, as well as abdominal cramps. It made me feel dizzy and out of it, too. I wouldn't recommend it to anyone."

Answered by AI

Clinical Trials for Viorele

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

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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

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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

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