Sprintec

Acne Vulgaris, moderate Vulvovaginal atrophy, Hot flashes + 9 more

Treatment

9 FDA approvals

20 Active Studies for Sprintec

What is Sprintec

Norgestimate

The Generic name of this drug

Treatment Summary

Ethinylestradiol is a synthetic estrogen hormone first developed in 1938 by two German scientists. This drug was designed to be more easily absorbed when taken orally. It is mainly used as a form of birth control in combination with other hormones. Ethinylestradiol was approved by the FDA in 1943.

Ortho Tri Cyclen

is the brand name

image of different drug pills on a surface

Sprintec Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Ortho Tri Cyclen

Norgestimate

1989

113

Approved as Treatment by the FDA

Norgestimate, commonly known as Ortho Tri Cyclen, is approved by the FDA for 9 uses which include Postmenopausal Osteoporosis and severe menopausal vulvovaginal atrophy .

Postmenopausal Osteoporosis

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

severe menopausal vulvovaginal atrophy

Used to treat severe menopausal vulvovaginal atrophy in combination with Estradiol

Oral Contraceptives

Used to treat Oral Contraceptives in combination with Ethinylestradiol

Acne Vulgaris

Used to treat moderate Acne vulgaris in combination with Ethinylestradiol

Osteoporosis, Postmenopausal

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

moderate Vulvovaginal atrophy

Used to treat moderate Vulvovaginal atrophy in combination with Estradiol

Hot flashes

Used to treat Menopause in combination with Estradiol

moderate Menopausal Vasomotor Symptoms

Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol

Menopause

Used to treat severe Vasomotor Symptoms Associated With Menopause in combination with Estradiol

Effectiveness

How Sprintec Affects Patients

Ethinylestradiol is a type of synthetic hormone used to reduce the risk of ovulation. It has a long-lasting effect when taken daily, and is generally considered to be a safe drug. Patients should be warned that it can increase the chance of blood clots.

How Sprintec works in the body

Ethinylestradiol is a hormone used in some forms of contraception. It works by reducing the release of hormones that cause ovulation, making it harder for sperm to reach an egg. It can also thicken cervical mucus, making it harder for sperm to move. Ethinylestradiol also reduces the ability of an egg to implant in the uterus and increases a protein that binds to hormones, making them less effective.

When to interrupt dosage

The measure of Sprintec is determined by the indicated affliction, such as Acne Vulgaris, Hormonal Contraception and Folate supplementation therapy. The dosage can be found in the table below, contingent upon the technique of administration.

Condition

Dosage

Administration

Oral Contraceptives

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

Polycystic Ovarian Syndrome

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

moderate Vulvovaginal atrophy

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

severe menopausal vulvovaginal atrophy

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

Menopause

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

Osteoporosis, Postmenopausal

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

Menorrhagia

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

Hirsutism

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

moderate Menopausal Vasomotor Symptoms

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

Hot flashes

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

Acne Vulgaris

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

Dysmenorrhea

, 0.25 mg, 0.215 mg, 0.18 mg, 0.09 mg, 0.645 mg

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

Warnings

Sprintec has 26 identified contraindications, which means it should not be taken when dealing with any of the conditions specified in the table below.

Sprintec Contraindications

Condition

Risk Level

Notes

Breast

Do Not Combine

Breast Cancer

Do Not Combine

high risk of arterial thrombotic disease

Do Not Combine

Pulse Frequency

Do Not Combine

Pulse Frequency

Do Not Combine

Hypersensitivity

Do Not Combine

Venous Thrombosis

Do Not Combine

Pulse Frequency

Do Not Combine

estrogen-sensitive cancer

Do Not Combine

Metrorrhagia

Do Not Combine

Liver Neoplasms

Do Not Combine

There are 20 known major drug interactions with Sprintec.

Common Sprintec Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The serum concentration of Abemaciclib can be increased when it is combined with Norgestimate.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Norgestimate.

Alectinib

Major

The metabolism of Alectinib can be increased when combined with Norgestimate.

Aminophylline

Major

The metabolism of Aminophylline can be increased when combined with Norgestimate.

Astemizole

Major

The metabolism of Astemizole can be increased when combined with Norgestimate.

Sprintec Toxicity & Overdose Risk

Women who overdose on the drug may experience bleeding, nausea, vomiting, breast tenderness, abdominal pain, drowsiness, and fatigue. Treatment for an overdose should include monitoring the patient's potassium and sodium levels as well as signs of metabolic acidosis.

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

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

There are 38 active studies investigating the utility of Sprintec for Folate supplementation therapy, Premenstrual Dysphoric Disorder and Menopausal symptoms.

Condition

Clinical Trials

Trial Phases

Dysmenorrhea

0 Actively Recruiting

Acne Vulgaris

0 Actively Recruiting

Osteoporosis, Postmenopausal

0 Actively Recruiting

Oral Contraceptives

0 Actively Recruiting

Menopause

0 Actively Recruiting

Polycystic Ovarian Syndrome

9 Actively Recruiting

Phase 1, Not Applicable

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Hirsutism

0 Actively Recruiting

Hot flashes

30 Actively Recruiting

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

moderate Vulvovaginal atrophy

0 Actively Recruiting

Menorrhagia

0 Actively Recruiting

severe menopausal vulvovaginal atrophy

0 Actively Recruiting

Sprintec Reviews: What are patients saying about Sprintec?

5

Patient Review

12/17/2021

Sprintec for Acne

This pill is really good for acne. I'm surprised at how well it works.

4.7

Patient Review

11/5/2021

Sprintec for Birth Control

I've been using this birth control for six years now and it's been great! No pregnancy scares, no mood swings or weight gain. The only downside is that I sometimes get muscle pain in my legs and feet.

4.7

Patient Review

9/30/2022

Sprintec for Birth Control

I'm really happy with this birth control. Not only did it get rid of my acne, but it also regulates my period so I know exactly when it's coming. Additionally, it made my periods lighter and alleviated many of my period pains. I almost never have cramps anymore!

4.7

Patient Review

9/17/2022

Sprintec for Painful Periods

I've been on Sprintec for over 11 years now and it's been great. My skin is amazing, I've never gotten pregnant, and it got rid of my ovarian cysts. Plus, because I take the pill every day (even on the sugar pill days), I don't get a period every month. I can't remember the last time I had one! But be warned: if you miss a pill, your mood will really be affected for the next day or two.

3.3

Patient Review

7/2/2022

Sprintec for Birth Control

I started this birth control December 2021. When I started it I was having horrible mood swings and just felt constantly angry. This is typical when I start a new birth control because I have been on a few. The main issue I have with this pill is that it has made me gain almost 10 pounds, despite no change in my diet or workout routine. Other than that it has been fine.

3

Patient Review

6/4/2022

Sprintec for Abnormally Long or Heavy Periods

I would not recommend this treatment. I experienced significant side effects, including but not limited to: bloating, fluid retention, and depression.

1.7

Patient Review

11/4/2022

Sprintec for Absence of Menstrual Periods

Unfortunately, this medication gave me a stroke after only taking two pills.

1.7

Patient Review

3/10/2022

Sprintec for Disease of Ovaries with Cysts

I was on this pill for six months to help with an ovarian cyst. The cyst is gone, but I started experiencing nausea soon after starting the pill. Now, the nausea is so bad that I'm up all night feeling sick. I'm considering quitting the pill altogether because it's just too miserable for me.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about sprintec

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

Is Sprintec a good birth control?

"The average rating for Sprintec from 1000 reviewers is 5.8 out of 10, with 41% having a positive experience and 33% having a negative experience."

Answered by AI

What kind of birth control is Sprintec?

"Sprintec is a combined oral contraceptive (COC) that contains both estrogen and progesterone hormones. It's a monophasic birth control meaning all active tablets contain the same doses of hormones. Sprintec is most effective when taken daily at the same time every day."

Answered by AI

Why was Sprintec discontinued?

"Some important information to remember is that Tri-Lo Sprintec was not taken off the market due to any safety concerns. The reason it was unavailable for a while was because of a patents dispute between the brand manufacturer Janssen Pharmaceuticals and the generic manufacturer Teva Pharmaceuticals. Recently, though, Tri-Lo Sprintec has reappeared."

Answered by AI

Will Sprintec cause weight gain?

"There is a chance that the hormones in Tri-Sprintec can make you want to eat more, but mostly the weight gain is from water retention and not from fat."

Answered by AI

Clinical Trials for Sprintec

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 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
Dietary Supplement

MusB Research LLC

Vidya USA Corporation

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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.

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Hormonal Effects on Brain Stimulation for Depression

18 - 40
All Sexes
Pittsburgh, PA

This study is investigating how two types of non-invasive brain stimulation, transcranial electrical stimulation (TES) and transcranial magnetic stimulation (TMS), affect brain activity, and whether combining them produces stronger or more consistent effects than either one used alone. The motivation for this comes from the observation that TMS, which is FDA-approved for treating depression, tends to work less well in postmenopausal women because lower estrogen levels reduce the brain's ability to respond to stimulation. The research team believes that pairing TMS with TES, which targets a different set of brain cells, may be able to overcome this hormonal barrier and make stimulation more effective. Participants will come into the lab for up to 24 visits over 8 months, beginning with an initial visit to establish the right stimulation settings, followed by a series of stimulation sessions in which brain activity is measured before and after receiving either TES, TMS, or both together. For female participants, sessions will be scheduled at specific points in the menstrual cycle to capture the natural monthly rise and fall of estrogen, while male participants will be scheduled on a comparable fixed interval as a comparison group. The insights gained from this study could directly inform the development of better, more reliable brain stimulation treatments for women with depression.

Waitlist Available
Has No Placebo

Carnegie Mellon University

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