Estrostep Fe

Endometriosis, Low Testosterone, Osteoporosis + 16 more

Treatment

20 Active Studies for Estrostep Fe

What is Estrostep Fe

Norethisterone

The Generic name of this drug

Treatment Summary

Norethisterone, also known as norethindrone, is a synthetic hormone used to imitate the effects of progesterone in the body. It is classified as a second-generation progestin and is used as contraception, hormone replacement therapy, and to treat irregular menstrual cycles and endometriosis. Norethisterone was first produced in 1951 and was first used as an oral contraceptive in 1962.

Necon

is the brand name

image of different drug pills on a surface

Estrostep Fe Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Necon

Norethisterone

1967

347

Effectiveness

How Estrostep Fe Affects Patients

Norethisterone is a medication taken by mouth that is used as a form of birth control or to treat other hormone-related issues such as menopause or endometriosis. It is a strong version of the hormone progesterone and works to change the cervix and uterus, and also blocks other hormones involved in ovulation. Taking norethisterone may slightly increase the risk of getting breast cancer, so patients should be aware of this and perform regular self-examinations for any lumps.

How Estrostep Fe works in the body

Norethisterone works by binding to progesterone receptors on target cells. This creates a chain reaction that affects genes in the reproductive tract, breast, pituitary, hypothalamus, and central nervous system. As a contraceptive, norethisterone makes the cervical mucus thicker and more difficult for sperm to pass through. It also changes the endometrium, making it less hospitable for implantation. Norethisterone also works on the hypothalamus and anterior pituitary to prevent the release of FSH and LH which stops follicular development, ovulation, and corpus luteum development. When used

When to interrupt dosage

The recommended dosage of Estrostep Fe is reliant upon the diagnosed condition, such as Atrophic, Fracture and Hormone Replacement Therapy. The quantity of dosage is variable, in accordance with the method of delivery (e.g. Oral or Tablet) outlined in the following table.

Condition

Dosage

Administration

Fracture

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Osteoporosis

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Atrophic

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

hypoestrogenism

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Hot flashes

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Birth Control

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Therapeutic procedure

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Endometriosis

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Menopause

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Estrogen Deprivation Symptoms

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Oral Contraceptives

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Low Testosterone

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Osteoporosis, Postmenopausal

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Endometriosis

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Primary Ovarian Insufficiency

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Hormonal Contraception

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

female castration

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Hormone Replacement Therapy

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Vasomotor System

0.014 mg/hour, , 0.025 mg/hour, 0.5 mg, 0.1 mg, 5.0 mg, 1.0 mg, 0.35 mg, 1.5 mg, 0.8 mg, 2.7 mg, 4.8 mg, 0.75 mg, 0.4 mg, 2.25 mg, 30.0 mg, 3.0 mg

, Patch, extended release, Patch, extended release - Transdermal, Transdermal, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral, Kit, Kit - Oral, Patch - Transdermal, Patch, Tablet, chewable, Tablet, chewable - Oral, Capsule - Oral, Capsule, Intramuscular; Oral; Topical

Warnings

Estrostep Fe has eight counterindications. It should not be taken in combination with any of the conditions given in the subsequent table.

Estrostep Fe Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Norethisterone may interact with Pulse Frequency

Liver Diseases

Do Not Combine

Thrombophilia

Do Not Combine

Vaginal Hemorrhage

Do Not Combine

Malignant Neoplasms

Do Not Combine

Benign hepatic neoplasm

Do Not Combine

Breast Cancer

Do Not Combine

Thromboembolism

Do Not Combine

There are 20 known major drug interactions with Estrostep Fe.

Common Estrostep Fe Drug Interactions

Drug Name

Risk Level

Description

Astemizole

Major

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

Axitinib

Major

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

Cabazitaxel

Major

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

Clomipramine

Major

The metabolism of Clomipramine can be increased when combined with Norethisterone.

Copanlisib

Major

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

Estrostep Fe Toxicity & Overdose Risk

The most toxic dose of oral contraceptives in mice has been found to be 6g/kg and in women is 42mg/kg. There have been no serious reports of effects from taking too many oral contraceptives, even in small children. Symptoms of overdosing may include nausea and vomiting.

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

Estrostep Fe Novel Uses: Which Conditions Have a Clinical Trial Featuring Estrostep Fe?

Currently, 160 active clinical trials are in progress to assess the potential of Estrostep Fe to treat Birth Control, Atrophic Uterine Conditions and Low Testosterone Levels.

Condition

Clinical Trials

Trial Phases

Birth Control

21 Actively Recruiting

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

Oral Contraceptives

1 Actively Recruiting

Not Applicable

Endometriosis

30 Actively Recruiting

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

Osteoporosis

28 Actively Recruiting

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

Low Testosterone

5 Actively Recruiting

Phase 4, Phase 2, Phase 1

Endometriosis

2 Actively Recruiting

Phase 4, Not Applicable

Hot flashes

19 Actively Recruiting

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

Estrogen Deprivation Symptoms

0 Actively Recruiting

Osteoporosis, Postmenopausal

0 Actively Recruiting

female castration

0 Actively Recruiting

Atrophic

5 Actively Recruiting

Phase 4, Not Applicable

Hormone Replacement Therapy

0 Actively Recruiting

Hormonal Contraception

0 Actively Recruiting

hypoestrogenism

1 Actively Recruiting

Phase 4

Fracture

0 Actively Recruiting

Vasomotor System

0 Actively Recruiting

Primary Ovarian Insufficiency

0 Actively Recruiting

Therapeutic procedure

0 Actively Recruiting

Menopause

0 Actively Recruiting

Estrostep Fe Reviews: What are patients saying about Estrostep Fe?

5

Patient Review

7/24/2009

Estrostep Fe for Acne

Out of the five different birth control pills I've tried, this one has been by far the best. Not only did it not give me mood swings or decrease my sex drive, but my breasts were also fuller and perkier while I was on this pill.

5

Patient Review

3/5/2015

Estrostep Fe for Birth Control

I've been using this pill for 18 years now and it's really the only one that works for me. I've never had any issues with my cycles, acne, weight gain, mood, or pregnancy scares while on it.

5

Patient Review

9/13/2016

Estrostep Fe for Birth Control

I've been taking this medication for about a decade now. I'm very pleased with it; though, like all birth control pills, it does lead to a slight reduction in libido. Additionally, the first month or so after starting the pill is always tough for me emotionally; however, my mood is much more stable once I get acclimated to the medication (and pre-menstrual mood swings are no longer an issue). My periods are also very light and painless now.

5

Patient Review

6/18/2011

Estrostep Fe for Birth Control

This treatment has been great for keeping my acne under control and preventing pregnancy; however, I have experienced extreme pain all over my body for the entire time I've been on it. I'm actually considering quitting this birth control because the pain is too much to bear, and it comes on very suddenly. It also brought my period on two weeks before it was supposed to, even though it kept me on a great and organized period schedule.

5

Patient Review

12/5/2010

Estrostep Fe for Birth Control

I experienced nausea and weight gain for the first few months, but it was worth it because this treatment has been effective. However, you do have to spend more money on pregnancy tests!

5

Patient Review

7/21/2008

Estrostep Fe for Birth Control

This acne treatment has been great for my skin, and I no longer have to deal with cramps or nausea during my period.

5

Patient Review

11/25/2007

Estrostep Fe for Birth Control

5

Patient Review

12/5/2007

Estrostep Fe for Disease of Ovaries with Cysts

5

Patient Review

2/12/2008

Estrostep Fe for Birth Control

5

Patient Review

4/9/2008

Estrostep Fe for Birth Control

5

Patient Review

7/9/2008

Estrostep Fe for Birth Control

5

Patient Review

12/17/2009

Estrostep Fe for Birth Control

I've been on a lot of different birth control pills, and this one was by far the worst. It had a lot of unpleasant side effects and it wasn't very good at regulating my heavy periods.

4.7

Patient Review

6/24/2008

Estrostep Fe for Birth Control

4.7

Patient Review

10/5/2008

Estrostep Fe for Birth Control

This medication has been great for me. I get a few small pimples before my period, but it's nothing compared to the acne I used to have. My periods are also much lighter now, which is fantastic.

4

Patient Review

8/6/2010

Estrostep Fe for Birth Control

I was hesitant to take this medication because I had migraines with previous birth control, but I didn't experience any headaches!

3.3

Patient Review

4/24/2013

Estrostep Fe for Birth Control

I'm on the fence about this pill; I love that it didn't affect my sex drive, mood, or weight. However, I started getting more acne from taking this medication-- which is supposed to help with acne! In addition, I had my period for two weeks the first month ( mostly spotting). I don't know if I'll stay on this pill because of the increase in acne.

2.3

Patient Review

11/25/2009

Estrostep Fe for Abnormally Long or Heavy Periods

I initially loved this birth control for its ability to regulate my periods and clear up acne. However, after switching to a stronger pill at the recommendation of my doctor, I found that my periods became very painful and difficult to manage. I would much prefer to switch back to this pill.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about estrostep fe

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

What are the side effects of Estrostep Fe?

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

Answered by AI

Is estrostep good for acne?

"Estrostep is a medication that contains norethindrone and ethinyl estradiol, which work to lower testosterone levels. It is considered the least effective of the three options for treating acne."

Answered by AI

Is Estrostep Fe discontinued?

"The therapeutic regimen for ESTROSTEP 21 and ESTROSTEP FE is the same, with the exception of the nontherapeutic ferrous fumarate tablets. ESTROSTEP 21 is no longer marketed, while ESTROSTEP FE (now simply known as ESTROSTEP) is still available."

Answered by AI

Does estrostep cause weight gain?

"Does the birth control pill Estrostep Fe cause weight gain? Some women report increased appetite and moderate weight gain (around 10 pounds over the course of a year) while taking Estrostep Fe."

Answered by AI

Clinical Trials for Estrostep Fe

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

Alison B Hamilton, PhD MPH

Image of UC San Diego in San Diego, United States.

Epione Device for Bone Conditions

18+
All Sexes
San Diego, CA

The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults. The main question is the determination of the rate of feasible procedures assisted by the Epione device Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be: * The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate * Additional CT or CBCT scans during the procedure.

Waitlist Available
Has No Placebo

UC San Diego (+2 Sites)

Sean Tutton, MD

Quantum Surgical

Image of University of Waterloo in Waterloo, Canada.

Virtual Chiropractic Intervention for Spinal Fracture

18+
All Sexes
Waterloo, Canada

This study will determine feasibility of a chiropractor delivered virtual intervention for individuals following osteoporotic vertebral fracture. This pilot trial will have two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization. VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics. A chiropractor (DC) completes a virtual assessment and then leads twelve 1:1 virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning. This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.

Recruiting
Has No Placebo

University of Waterloo

Have you considered Estrostep Fe clinical trials?

We made a collection of clinical trials featuring Estrostep Fe, we think they might fit your search criteria.
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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 University Hospitals Cleveland Medical Center in Cleveland, United States.

Ketamine for Pelvic Pain

18 - 89
Female
Cleveland, OH

The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA. Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.

Phase 4
Waitlist Available

University Hospitals Cleveland Medical Center

Morgan Cheeks, MD

Have you considered Estrostep Fe clinical trials?

We made a collection of clinical trials featuring Estrostep Fe, we think they might fit your search criteria.
Go to Trials

Have you considered Estrostep Fe clinical trials?

We made a collection of clinical trials featuring Estrostep Fe, we think they might fit your search criteria.
Go to Trials