Sprintec

Acne Vulgaris, moderate Vulvovaginal atrophy, Hot flashes + 9 more
Treatment
9 FDA approvals
20 Active Studies for Sprintec

What is Sprintec

NorgestimateThe Generic name of this drug
Treatment SummaryEthinylestradiol 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 Cyclenis 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 PatientsEthinylestradiol 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 bodyEthinylestradiol 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
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
Oral Contraceptives
, 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 RiskWomen 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
1 Actively Recruiting
Not Applicable
Acne Vulgaris
0 Actively Recruiting
Osteoporosis, Postmenopausal
0 Actively Recruiting
Oral Contraceptives
1 Actively Recruiting
Not Applicable
Menopause
0 Actively Recruiting
Polycystic Ovarian Syndrome
6 Actively Recruiting
Not Applicable, Phase 1
moderate Menopausal Vasomotor Symptoms
0 Actively Recruiting
Hirsutism
0 Actively Recruiting
Hot flashes
19 Actively Recruiting
Not Applicable, Phase 4, Phase 2, Early Phase 1, Phase 3
moderate Vulvovaginal atrophy
0 Actively Recruiting
Menorrhagia
3 Actively Recruiting
Phase 1, Phase 2, Not Applicable
severe menopausal vulvovaginal atrophy
0 Actively Recruiting

Sprintec Reviews: What are patients saying about Sprintec?

5Patient Review
12/17/2021
Sprintec for Acne
This pill is really good for acne. I'm surprised at how well it works.
4.7Patient 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.
4.7Patient 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!
4.7Patient 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.
3.3Patient 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.
3Patient 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.
1.7Patient Review
11/4/2022
Sprintec for Absence of Menstrual Periods
Unfortunately, this medication gave me a stroke after only taking two pills.
1.7Patient 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 Goldring Center for High Performance Sport in Toronto, Canada.

Menstrual Cycle vs. Birth Control Pills for Protein Metabolism

18 - 40
Female
Toronto, Canada
The muscles of the body are constantly breaking down old proteins and building new ones. These two processes, protein breakdown and protein synthesis, together are known as protein turnover. Protein turnover is essential for maintaining healthy muscle. Despite its importance, females have historically been underrepresented in protein metabolism research. A long-standing assumption has been that fluctuations in female sex hormones such as estrogen and progesterone, whether across the natural menstrual cycle or in individuals using oral contraceptives (OCs), make metabolism and training responses too variable to study. Because of this, many researchers have excluded female participants for logistical reasons. Resistance exercise, such as weightlifting, is the most effective way to increase muscle size and strength. Each resistance-training session triggers muscle protein synthesis (MPS), the process by which new muscle proteins are built. Consuming dietary protein or individual amino acids further increases the rate at which new proteins are formed. Over time, higher rates of protein synthesis support muscle growth and the maintenance of other lean tissues in the body. The purpose of this study is to examine how menstrual cycle phases and OC use influence the synthesis of proteins in both muscle tissue and the rest of the body. Improving scientific understanding in this area will support more effective, evidence-based training and nutrition recommendations for females.
Recruiting
Has No Placebo
Goldring Center for High Performance Sport
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 Center for Human Nutrition in Fayetteville, United States.

Higher Protein Diet for PCOS

18 - 50
Female
Fayetteville, AR
Polycystic ovary syndrome (PCOS) is a significant public health problem and is one of the most common hormonal disturbances affecting women of reproductive age. Women with PCOS are often insulin resistant, increasing their risk for cardiometabolic health problems (e.g., type 2 diabetes, heart disease, high blood pressure, sleep apnea, anxiety, depression, and stroke) especially if they are overweight. Lifestyle modifications, including dietary changes and regular physical activity, may alleviate metabolic dysfunction in women with PCOS and are often the first line of management for patients with PCOS. Several studies have identified protein as a key nutrient for regulation of energy balance, maintenance of skeletal muscle mass, and improving cardiometabolic health across the lifespan. However, the effect of increased protein intake (30% of total energy intake) on cardiometabolic health in women with PCOS has not been well-defined and mechanisms for these effects have not been identified. There is an evident need for well-designed, randomized controlled trials evaluating the efficacy of increased protein intake in women with PCOS on markers of cardiometabolic health. Preliminary data from collaborative projects with the investigators on this proposal suggest that increasing protein in the diet has the potential to improve markers of cardiometabolic health, potentially through improvements in body composition and/or changes in cortisol, energy metabolism, inflammation, and neurological regulators
Recruiting
Has No Placebo
Center for Human Nutrition
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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
Image of School of Allied Health Professions in Loma Linda, United States.

Seed Cycling for Menstrual Disorder

18 - 45
Female
Loma Linda, CA
The purpose of this research is to investigate the impact of seed cycling on menstrual regularity, cramps, and pre-menstrual symptoms in women with an irregular menstrual cycle and/or dysmenorrhea. The research seeks to provide evidence-based insights into the potential benefits of seed cycling as a holistic approach to women's reproductive health. It is expected that your participation will last 3 months. Procedures and Activities. You will be provided with and asked to consume specific seeds daily. The seeds are to be consumed as follows: follicular phase (the period from the first day of menstruation (day 1) to ovulation (day 14) in a typical 28-day cycle): 1 tablespoon flax seeds and 1 tablespoon pumpkin seeds, and luteal phase (the period between ovulation and the start of the next period; typically days 15-28): 1 tablespoon sunflower seeds and 1 tablespoon sesame seeds. Before the intervention and once monthly for a total of 3 cycles, you will be asked to complete an online menstrual health symptom questionnaire (MHSQ) and keep track of your menstrual cycle days on the built-in health tracking app on your electronic device. Risks. Some of the foreseeable risks or discomforts of your participation include the potential for mild gastrointestinal side effects, the potential for allergic reactions, and the possibility of no significant benefit. Benefits. Possible benefits include the potential for improved menstrual cycle regularity, the potential for a reduction in premenstrual syndrome (PMS) symptoms, and the potential for nutritional benefits. Societal benefits include additional knowledge on seed cycling to help manage menstrual regularity and PMS symptoms.
Waitlist Available
Has No Placebo
School of Allied Health Professions
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Image of Noll Laboratory in University Park, United States.

Estradiol and Elagolix for Menopause

42 - 64
Female
University Park, PA
The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men. Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.
Phase 4
Recruiting
Noll LaboratoryW. Larry Kenney, Ph.D.
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