Introvale

Endometrial Hyperplasia, Endometriosis, Hot flashes + 6 more

Treatment

7 FDA approvals

20 Active Studies for Introvale

What is Introvale

Levonorgestrel

The Generic name of this drug

Treatment Summary

Levonorgestrel (LNG), also known as Plan B, is a hormone used in contraception and hormone therapy. It can come in a single dose, an intrauterine device, or a subdermal implant. Levonorgestrel is the most widely used emergency contraceptive, and was approved by the FDA in 1982. It has been found to be highly effective with few estrogenic side effects compared to other emergency contraceptives.

Triphasil-21

is the brand name

Introvale Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Triphasil-21

Levonorgestrel

1984

243

Approved as Treatment by the FDA

Levonorgestrel, also known as Triphasil-21, is approved by the FDA for 7 uses including Osteoporosis, Postmenopausal and Menopause .

Osteoporosis, Postmenopausal

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

Menopause

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

Postmenopausal Osteoporosis

Used to treat Postmenopausal Osteoporosis in combination with Estradiol

moderate Menopausal Vasomotor Symptoms

Used to treat moderate Menopausal Vasomotor Symptoms in combination with Estradiol

Has had at least 1 child

Emergency Contraception

Hot flashes

Used to treat Menopause in combination with Estradiol

Effectiveness

How Introvale Affects Patients

Levonorgestrel is a type of contraceptive that works by preventing ovulation, fertilization, and implantation. As an emergency contraceptive pill it can prevent pregnancy up to 72 hours after intercourse, and its effectiveness is 89%. When used in intrauterine or implantable devices, levonorgestrel is more than 99% successful in preventing pregnancy. It can also be used as part of a hormonal therapy to reduce the risk of endometrial cancer caused by estrogen.

How Introvale works in the body

Levonorgestrel has multiple mechanisms of action. It suppresses ovulation by slowing the release of hormones from the hypothalamus that would normally cause the release of an egg. It also makes the cervical mucus thicker and harder for sperm to pass through, reducing the risk of fertilization. Finally, it can act as an anti-estrogen to reduce the risk of endometrial cancer in those taking estrogen-based hormone therapy.

When to interrupt dosage

The measurement of Introvale is based upon the determined illness, including Endometrial Hyperplasia, Emergency Contraception and Hypermenorrhea. The amount of dosage is contingent upon the technique of delivery outlined in the table below.

Condition

Dosage

Administration

Osteoporosis, Postmenopausal

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

Endometrial Hyperplasia

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

Endometriosis

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

Hot flashes

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

Emergency Contraception

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

Menopause

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

Menorrhagia

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

Has had at least 1 child

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

moderate Menopausal Vasomotor Symptoms

, 0.75 mg, 1.5 mg, 52.0 mg, 1.39 mg, 0.15 mg, 0.1 mg, 36.0 mg, 0.25 mg, 0.125 mg, 0.075 mg, 13.5 mg, 0.09 mg, 1.5 mg/mg, 19.5 mg, 0.0015 mg/hour, 0.03 mg, 0.05 mg, 0.45 mg, 2.6 mg, 0.3 mg

Oral, Kit - Oral, , Kit, Tablet - Oral, Tablet, Subcutaneous, Intrauterine device - Intrauterine, Intrauterine device, Intrauterine, Transdermal, Patch, Patch - Transdermal, Insert, extended release, Insert, extended release - Intrauterine, Implant, Implant - Subcutaneous, Tablet, film coated - Oral, Tablet, film coated

Warnings

Introvale has forty-three contraindications, and its utilization should be avoided if any of the conditions in the subsequent table are present.

Introvale Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Levonorgestrel may interact with Pulse Frequency

Abortion, Septic

Do Not Combine

undiagnosed abnormal genital bleeding

Do Not Combine

Abortion, Spontaneous

Do Not Combine

HCG elevated

Do Not Combine

Pelvic Infection

Do Not Combine

Vaginitis

Do Not Combine

Acute Coryza

Do Not Combine

Breast Neoplasms

Do Not Combine

Uterine Cervicitis

Do Not Combine

Communicable Diseases

Do Not Combine

Gonorrhea

Do Not Combine

Breast Cancer

Do Not Combine

Intrauterine Devices

Do Not Combine

Liver Neoplasms

Do Not Combine

congenital or aquired uterine abnormality

Do Not Combine

Chlamydia Infections

Do Not Combine

Hypersensitivity

Do Not Combine

Emergency Contraception

Do Not Combine

Endocarditis, Bacterial

Do Not Combine

Vaginosis, Bacterial

Do Not Combine

suspected pregnancy

Do Not Combine

Uterine Cervicitis

Do Not Combine

Uterine Neoplasms

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Breast Neoplasms

Do Not Combine

Uterine Cervical Neoplasms

Do Not Combine

Fibroid Tumor

Do Not Combine

Endometritis

Do Not Combine

chlamydial cervical infection

Do Not Combine

PAP Test Abnormalities

Do Not Combine

Liver Failure, Acute

Do Not Combine

Uterine anomaly distorting uterine cavity

Do Not Combine

Breast Cancer

Do Not Combine

Cervical Dysplasia

Do Not Combine

Thromboembolism

Do Not Combine

Bacterial Vaginosis

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Breast

Do Not Combine

Vaginal Bleeding

Do Not Combine

Bacterial Vaginosis

Do Not Combine

Pelvic Inflammatory Disease

Do Not Combine

Gonorrhea

Do Not Combine

There are 20 known major drug interactions with Introvale.

Common Introvale Drug Interactions

Drug Name

Risk Level

Description

Astemizole

Major

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

Axitinib

Major

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

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Levonorgestrel.

Copanlisib

Major

The metabolism of Copanlisib can be decreased when combined with Levonorgestrel.

Crizotinib

Major

The metabolism of Crizotinib can be decreased when combined with Levonorgestrel.

Introvale Toxicity & Overdose Risk

The lowest toxic dose of levonorgestrel in rats has been found to be greater than 5000mg/kg. Overdosing on this drug may cause nausea and bleeding. People who overdose on levonorgestrel should receive supportive care and contact a local poison control center. There is no specific antidote for levonorgestrel overdose.

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

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

99 active studies are in progress to evaluate the potential of Introvale for treating Postmenopausal Osteoporosis, Women who have had at least one child and Endometrial Hyperplasia.

Condition

Clinical Trials

Trial Phases

Endometriosis

27 Actively Recruiting

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

Hot flashes

19 Actively Recruiting

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

Menorrhagia

5 Actively Recruiting

Phase 1, Phase 2, Not Applicable

Has had at least 1 child

0 Actively Recruiting

Endometrial Hyperplasia

4 Actively Recruiting

Not Applicable, Phase 2, Phase 3

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Menopause

0 Actively Recruiting

Osteoporosis, Postmenopausal

0 Actively Recruiting

Emergency Contraception

1 Actively Recruiting

Phase 4

Introvale Reviews: What are patients saying about Introvale?

5

Patient Review

11/14/2015

Introvale for Abnormally Long or Heavy Periods

I've had great results with this birth control. I highly recommend it to other women who are struggling with bad menstrual cycles.

5

Patient Review

7/12/2017

Introvale for Birth Control

I've been taking this pill for over seven years and it's really changed my life. I used to have terrible breakouts, but they cleared up within a few weeks of starting this medication. Additionally, my periods are much lighter and less painful than they used to be, and I only get them every three months now.

4.7

Patient Review

10/11/2015

Introvale for Abnormally Long or Heavy Periods

I've been using Introvale for about four months now, and it's greatly improved my quality of life. I have light to medium spotting for only four days out of the month, as opposed to an entire week. The cramps are still there unfortunately, but they're manageable.

4.3

Patient Review

5/4/2015

Introvale for Abnormally Long or Heavy Periods

This birth control has been a game-changer for me. I used to have my periods every two weeks, and they would last for 11 days! But since starting this prescription, everything has cleared up and I haven't had any problems. There were a few rough patches in the beginning where I felt nauseous and spotted a bit, but things evened out quickly and I've been feeling great ever since.

3.7

Patient Review

7/11/2016

Introvale for Abnormally Long or Heavy Periods

I was on this for three months and saw a significant increase in my appetite. I put on 10lbs as a result. Thankfully, I went back to Quasense which curbed my hunger much more effectively.

3.7

Patient Review

8/9/2016

Introvale for Birth Control

I've been bleeding more and for longer since I switched to this pill. I'm not a fan, and would prefer to go back to the other birth control pills I was taking before.

3.7

Patient Review

5/20/2016

Introvale for Birth Control

I started this pill about a month and a half ago, and just recently started experiencing the worst cramps I've had since I got my period at 13. I was previously on Quasense but when I called in for a refill, my doctor switched me to this pill. I never had any problems with Quasense. Additionally, I've been trying to lose weight for the past few months without any success; in fact, I haven't even lost a pound. Needless to say, I'll be calling my doctor to switch back to Quasense.

3.3

Patient Review

10/8/2013

Introvale for Birth Control

I was on Quasense for many years- everything was great, last month the pharmacy switched my generic (thanks Obama). I have been having mood swings,(stress, depression, anger) nausea, fibrocystic tissue pain, cramping. What is the deal? How could it make you feel so bad? I talked to my doctor and she said that there's a chance my body just needs to adjust to the new medication.

3.3

Patient Review

4/24/2016

Introvale for Birth Control

I was on Quasense for 6 years, and was switched because I didn't have insurance. This pill is terrible in comparison; I've been spotting and lightly bleeding non-stop for the past two months, plus my period came a month early. The cramps are worse than ever and I constantly feel gassy and dizzy.

3.3

Patient Review

3/22/2017

Introvale for Painful Periods

I've been taking this for two months now. The first month went great—no period and only light cramping around the time when my period would have started. But then, halfway through the second month, I started spotting for six days before having a full-blown period with really dark blood. So far, day nine of my period, and I'm hoping it will end soon!

3

Patient Review

9/17/2013

Introvale for Birth Control

I was on Jolessa for several years and it worked great, but I was switched to this by the pharmacy and I've been struggling ever since. I'm incredibly depressed and have even had thoughts of suicide. This medication has also made it difficult to handle work/home/school stressors. However, I haven't experienced any issues with bleeding or cramping or weight gain.

3

Patient Review

11/19/2019

Introvale for Birth Control

I used Quasense for years. My 4th month using Introvale, I had a stroke.

2.7

Patient Review

3/25/2017

Introvale for Abnormally Long or Heavy Periods

I just completed the second month of this three-month package, and I have to say I'm disappointed. The first month was great, but the second month I started spotting randomly, and now for the last two weeks of the pack I've had my period nonstop.

2.7

Patient Review

2/19/2018

Introvale for Acne

I experienced some initial success with this treatment, but then started noticing breakouts in new areas of my face. I'm not sure if the two are related, but I'm switching back to my old birth control pill just in case.

2.3

Patient Review

6/14/2020

Introvale for Birth Control

I'm disappointed with this medication. I've been bleeding constantly since starting it over three weeks ago. The whole point of taking this pill was to reduce the frequency of my periods, not make them daily occurrences.

2

Patient Review

4/1/2019

Introvale for Birth Control

I started this birth control pill after having issues with other brands and excessive bleeding. The day after I took my first pill, I got around 15-20 huge cystic pimples all over my face-- the worst acne breakout of my life. Over a month has passed and nothing has changed with my skin; if anything, it's gotten worse. Definitely not a good pill for acne-prone skin!

1

Patient Review

11/14/2017

Introvale for Abnormally Long or Heavy Periods

I've taken Jolessa for years, but my pharmacy changed me to this garbage. I take BC to keep my periods short since I suffer from PMDD, but now I'm experiencing 2 week long periods and bad cramping! This drug is a total fail!
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about introvale

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

Is Introvale generic for Seasonale?

"Sandoz has announced that the FDA has approved their generic equivalent of Duramed's Seasonale, Introvale (levonorgestrel and ethinyl estradiol tablets, USP)."

Answered by AI

What is Introvale medicine?

"Introvale is a prescription medicine used to prevent pregnancy by means of contraception. It may be used alone or with other medications, and is classified as an Estrogen/Progestin drug under the subcategory of Contraceptives, Oral. Its efficacy in children has not been established prior to menarche."

Answered by AI

Is Amethia and Ashlyna the same?

"The drug Amethia is used as a contraceptive to prevent pregnancy. The generic version of Amethia is Ethinyl Estradiol/Norethindrone."

Answered by AI

What is Introvale generic for?

"Introvale is a combined oral contraceptive that contains levonorgestrel and ethinyl estradiol. It is indicated for use by women to prevent pregnancy. Introvale is available in generic form."

Answered by AI

Clinical Trials for Introvale

Image of Vanderbilt Center for Women's Health in Nashville, United States.

Podcast for Pelvic Pain

18+
Female
Nashville, TN

The purpose of this research study is to study the impact of an educational podcast on pelvic pain. If you decide to take part in this research, you may receive the standard treatment for pelvic pain, or you may receive the standard treatment plus access to an educational podcast series. You will be randomly assigned to receive access to the podcast or to receive standard care. If you are assigned to receive access to the podcast, participating in this research will involve listening to a podcast series. All participants will complete three ten-minute online surveys over the course of 6 months. Reasons you may choose to participate in this research are if you want to learn more about pelvic pain and possible benefits of listening to the podcast, such as improved quality of life, reduced stigma, or increased satisfaction with your medical care.

Recruiting
Has No Placebo

Vanderbilt Center for Women's Health

Image of University of Iowa/Holden Comprehensive Cancer Center in Iowa City, United States.

Progestins for Endometrial Cancer

18+
Female
Iowa City, IA

This phase II trial tests compares the effect of progestins, megestrol acetate to micronized progesterone, in treating patients with endometrial cancer and precancers of the uterus (atypical endometrial hyperplasia) before surgery. Progestins, similar to the natural hormone progesterone, are approved drugs used in birth control and hormone replacement pills, and some can treat uterine endometrial cancers. In the initial comparison of this rotating umbrella trial, megestrol acetate, a progestin, will be compared to micronized progesterone, a form of natural progesterone that is a hormone produced by body normally. Hormone therapy using megestrol acetate and micronized progesterone may be effective in treating patients with endometrial cancer or atypical endometrial hyperplasia before surgery, and understanding the tissue effects of each agent on the malignant endometrium will uncover novel mechanistic and biomarker data to understand how best to advanced hormone therapy for endometrial cancer.

Phase 2
Waitlist Available

University of Iowa/Holden Comprehensive Cancer Center (+3 Sites)

Carolyn Y Muller

Have you considered Introvale clinical trials?

We made a collection of clinical trials featuring Introvale, we think they might fit your search criteria.
Go to Trials
Image of VA Greater Los Angeles Healthcare System, West Los Angeles, CA in West Los Angeles, United States.

EBQI Strategies for Women's Health

Any Age
All Sexes
West Los Angeles, CA

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

Waitlist Available
Has No Placebo

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Erin P Finley, PhD MPH

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.

Recruiting
Online Trial

Lindus Health - DECENTRALIZED STUDY

Navid Khodaparast, PhD

Spark Biomedical, Inc.

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
Waitlist Available

Erevna Innovations Inc.

Andreas Nikolis, MD, PhD

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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

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