Mono-Linyah

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

Treatment

9 FDA approvals

20 Active Studies for Mono-Linyah

What is Mono-Linyah

Norgestimate

The Generic name of this drug

Treatment Summary

Ethinylestradiol is a synthetic form of estrogen that was developed in 1938 by Hans Herloff Inhoffen and Walter Hohlweg at Schering. It was created to be more bioavailable when taken orally, and eventually replaced mestranol in contraceptive pills. The FDA approved ethinylestradiol in 1943.

Ortho Tri Cyclen

is the brand name

image of different drug pills on a surface

Mono-Linyah 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 Mono-Linyah Affects Patients

Ethinylestradiol is a synthetic form of estrogen that stops the body from releasing hormones that cause ovulation, and reduces the development of blood vessels in the uterus. This drug has a long lasting effect and is generally safe, although it can increase the risk of blood clots. Patients should be informed of this risk before taking the medication.

How Mono-Linyah works in the body

Ethinylestradiol is a synthetic form of the hormone estrogen. It is used in combined oral contraceptives to stop ovulation, thickening cervical mucus to block sperm, and prevent changes in the uterus that could lead to pregnancy. Ethinylestradiol also keeps the uterus from becoming too vascular and increases a protein that binds to hormones in the body.

When to interrupt dosage

The recommended dosage of Mono-Linyah is contingent upon the established condition, including Acne Vulgaris, Hormonal Contraception and Folate supplementation therapy. The measure of dosage diverges, in relation to the mode of delivery as specified in the table below.

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

Mono-Linyah has twenty-six contraindications and should not be taken concurrently with any of the circumstances detailed in the table below.

Mono-Linyah 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 Mono-Linyah.

Common Mono-Linyah 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.

Mono-Linyah Toxicity & Overdose Risk

Women who overdose on birth control may experience irregular bleeding, nausea, vomiting, tenderness in the breasts, abdominal pain, drowsiness, and fatigue. Treatment for overdose should include monitoring of electrolyte levels and signs of metabolic acidosis, as well as providing supportive care.

Mono-Linyah Novel Uses: Which Conditions Have a Clinical Trial Featuring Mono-Linyah?

There are 38 clinical trials in progress to assess the potential of Mono-Linyah to provide Folate supplementation therapy, alleviate Premenstrual Dysphoric Disorder and address the symptoms of Menopause.

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

7 Actively Recruiting

Not Applicable, Phase 1

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Hirsutism

0 Actively Recruiting

Hot flashes

18 Actively Recruiting

Not Applicable, Phase 2, Phase 4, 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

Mono-Linyah Reviews: What are patients saying about Mono-Linyah?

4.7

Patient Review

1/13/2020

Mono-Linyah for Acne

I went with Mono-Linyah to treat my acne and it's been great. At the beginning, my hormones were all over the place which led to some anxiety. However, after four months things evened out and now my skin is almost completely clear. I've had no other side effects besides slightly worse cramping during my period and larger breasts.

4.7

Patient Review

4/7/2021

Mono-Linyah for Birth Control

I've been pleased with this birth control so far. It caused a bit of nausea at first (but that went away), and my breasts are now sore. Otherwise, I haven't had any real negative reactions like mood swings. I'm also not spotting, which is great since I was on the mini pill before and getting a period every two weeks.

4.7

Patient Review

7/11/2018

Mono-Linyah for Birth Control

I haven't had any issues with side effects and my periods have been regular. The packaging could be better, but it's not a big deal. I'm just glad the medication works.

4.3

Patient Review

6/11/2018

Mono-Linyah for Acne

This birth control has done wonders for my acne. I haven't had any negative side effects that I can speak of and my skin has never looked better.

4.3

Patient Review

5/21/2022

Mono-Linyah for Painful Periods

This birth control has been great in terms of preventing cramps and other period side effects. However, it's worth noting that it's had negative impacts on my mental health. Overall, though, it's manageable.

4

Patient Review

11/26/2021

Mono-Linyah for Painful Periods

I was extremely pleased with how this medication alleviated my PCOS symptoms; however, I experienced prolonged bleeding which became quite burdensome.

4

Patient Review

5/14/2018

Mono-Linyah for Birth Control

The medication works well, but the packaging is very difficult to use. I've lost pills because of this before, which is frustrating.

3

Patient Review

2/6/2019

Mono-Linyah for Birth Control

I was taking spryntec for a while, but when I changed pharmacists they switched me to this. It does its job well enough, but I constantly feel nauseous and grossed out. I stopped taking it and went back to the doctor.

2.7

Patient Review

5/4/2022

Mono-Linyah for Painful Periods

This medication helps with my periods, but unfortunately I've had more migraines since taking it. For me, the pros don't outweigh the cons.

Patient Q&A Section about mono-linyah

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

What kind of birth control is Mono-Linyah?

"Mono-Linyah is a birth control pill that contains two different hormones: norgestimate (a progestin) and ethinyl estradiol (an estrogen)."

Answered by AI

What is Mono-Linyah generic for?

"Mono-Linyah is a generic birth control pill for women. The hormones in Mono-Linyah, norgestimate and ethinyl estradiol, prevent ovulation and change the cervical and uterine linings to block the movement of sperm and prevent implantation of a fertilized egg."

Answered by AI

What are the side effects of Mono-Linyah birth control?

"The following side effects may occur: nausea, vomiting, headache, bloating, breast tenderness, swelling of the ankles/feet (fluid retention), or weight change. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use."

Answered by AI

Is Mono-Linyah a good birth control?

"While Mono-Linyah is not 100% effective, it is a safe and effective method of birth control when used properly. If you miss a dose or are late taking your medication, use backup birth control until your next cycle to ensure you are fully protected."

Answered by AI

Clinical Trials for Mono-Linyah

Image of Lindus Health - DECENTRALIZED STUDY in Boston, United States.

Neurostimulation for Heavy Menstrual Bleeding

14 - 45
Female
Boston, MA

The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria). During the first two consecutive menstrual cycles (M1 - M2, "Baseline Phase"), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual cramp pain will be assessed with a Numerical Rating Scale (NRS), daily throughout the duration of the menstruation phase of their two baseline menstrual cycles. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the RAND Short-Form 36 (RAND-36). Menstrual-related quality of life assessments will also be conducted on the final day of each menstruation using the Menstrual Bleeding Questionnaire (MBQ) in the adult cohort, and the adolescent version (aMBQ) in the adolescent cohort. During the following three consecutive menstruations (M3 - M5, "Treatment Phase"), participants will self-administer one 2-hour sham or active tAN session daily, beginning Day 1 of menstruation through the final day of menstruation in each menstrual cycle. Blood loss (via the PBAC) and menstrual cramp pain (via the NRS) will be assessed daily throughout the duration of each menstruation. Quality of life will be assessed with the CMSS, RAND-36, and the MBQ (adults) or aMBQ (adolescents) on the final day of each menstruation. A device usability survey will be completed at the end of M3 and M5. Participants will exit the study after the final day of M5.

Waitlist Available
New This Month

Lindus Health - DECENTRALIZED STUDY

Navid Khodaparast, PhD

Spark Biomedical, Inc.

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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We made a collection of clinical trials featuring Mono-Linyah, we think they might fit your search criteria.
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Image of Center for Human Nutrition in Fayetteville, United States.

Protein Meals for Polycystic Ovary Syndrome

18 - 50
Female
Fayetteville, AR

Polycystic ovary syndrome (PCOS) is a common endocrine disorder characterized by insulin resistance, hyperandrogenism, and reproductive dysfunction. Dietary strategies that improve postprandial insulin and glucose responses are central to managing metabolic symptoms in PCOS. Meals higher in protein can attenuate postprandial glycemia and enhance satiety, but the effects may vary by protein source. Animal sources of protein typically have higher essential amino acid content and insulinogenic potential, whereas plant proteins offer fiber and phytochemicals that may influence glycemic dynamics differently. Few studies have directly compared the acute metabolic effects of plant versus animal protein in women with PCOS. Given the distinct pathophysiology of PCOS, extrapolating findings from healthy populations may be misleading. Understanding protein-specific effects on postprandial insulin, glucose, and appetite-regulating hormones in this group is essential for targeted nutrition guidance. Additionally, plant-based diets are increasingly promoted for cardiometabolic health, but their acute effects in insulin-resistant women remain underexplored. This study will assess whether plant and animal protein meals elicit differential postprandial responses in women with PCOS. Findings may inform dietary recommendations aimed at improving metabolic outcomes in this high-risk population.

Recruiting
Has No Placebo

Center for Human Nutrition

Jamie I Baum, PhD

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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We made a collection of clinical trials featuring Mono-Linyah, we think they might fit your search criteria.
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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 Laboratory

W. Larry Kenney, Ph.D.

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We made a collection of clinical trials featuring Mono-Linyah, we think they might fit your search criteria.
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