Lunelle

Low Testosterone, hypoestrogenism, Menopause + 1 more

Treatment

5 FDA approvals

5 Active Studies for Lunelle

What is Lunelle

Estradiol cypionate

The Generic name of this drug

Treatment Summary

Estradiol Cypionate is a form of the female hormone estrogen. It is commonly used to treat menopausal symptoms like hot flashes, vaginal dryness, mood changes, irregular menses, chills, and sleeping problems. Estradiol Cypionate is available as an intramuscular injection under the brand name Depo-Estradiol. Normally, women’s bodies naturally produce estrogen from the ovarian follicle during their menstrual cycle. After menopause, estrogen is produced by conversion of androstenedione from the adrenal cortex. Estradiol Cypionate is a pro-drug

Depo-Estradiol

is the brand name

Lunelle Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Depo-Estradiol

Estradiol cypionate

1979

2

Approved as Treatment by the FDA

Estradiol cypionate, also called Depo-Estradiol, is approved by the FDA for 5 uses like Hypogonadism and Menopause .

Hypogonadism

Helps manage Hypogonadism

Menopause

moderate Menopausal Vasomotor Symptoms

Low Testosterone

Helps manage Hypogonadism

hypoestrogenism

Helps manage hypoestrogenism

Effectiveness

How Lunelle Affects Patients

Estrogen works in the body by binding to two different types of receptors (Estrogen Receptor Alpha and Estrogen Receptor Beta) and a third type of receptor known as G Protein-coupled Estrogen Receptor. These receptors are located in different parts of the body, including the breasts, uterus, ovaries, skin, prostate, bone, fat, and brain. When estrogen binds to these receptors it can cause a range of effects.

How Lunelle works in the body

Estradiol works by entering cells, such as in female organs, breasts, the hypothalamus, and the pituitary. Once inside the cell, it binds to a receptor, which causes the cell to produce proteins that express the effects of estradiol. These proteins increase the production of proteins in the liver that bind hormones, as well as suppress a hormone that stimulates fertility. These changes reverse some of the symptoms of menopause and low estrogen levels.

When to interrupt dosage

The measure of Lunelle is contingent upon the diagnosed circumstance, including Low Testosterone, hypoestrogenism and Menopause. The dosage amount is contingent upon the technique of delivery, as outlined in the table beneath.

Condition

Dosage

Administration

Low Testosterone

, 5.0 mg/mL, 50.0 mg/mL

, Intramuscular, Injection, Injection - Intramuscular, Injection, suspension, Injection, suspension - Intramuscular

hypoestrogenism

, 5.0 mg/mL, 50.0 mg/mL

, Intramuscular, Injection, Injection - Intramuscular, Injection, suspension, Injection, suspension - Intramuscular

Menopause

, 5.0 mg/mL, 50.0 mg/mL

, Intramuscular, Injection, Injection - Intramuscular, Injection, suspension, Injection, suspension - Intramuscular

moderate Menopausal Vasomotor Symptoms

, 5.0 mg/mL, 50.0 mg/mL

, Intramuscular, Injection, Injection - Intramuscular, Injection, suspension, Injection, suspension - Intramuscular

Warnings

There are 20 known major drug interactions with Lunelle.

Common Lunelle Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be increased when combined with Estradiol cypionate.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Estradiol cypionate.

Alectinib

Major

The metabolism of Alectinib can be increased when combined with Estradiol cypionate.

Aminophylline

Major

The metabolism of Aminophylline can be increased when combined with Estradiol cypionate.

Anastrozole

Major

The therapeutic efficacy of Anastrozole can be decreased when used in combination with Estradiol cypionate.

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

19 active studies are being conducted to investigate the potential of Lunelle to ameliorate hypoestrogenism, Low Testosterone and Menopausal symptoms.

Condition

Clinical Trials

Trial Phases

hypoestrogenism

1 Actively Recruiting

Phase 4

Menopause

0 Actively Recruiting

moderate Menopausal Vasomotor Symptoms

0 Actively Recruiting

Low Testosterone

4 Actively Recruiting

Phase 4, Phase 2, Phase 1

Patient Q&A Section about lunelle

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

How effective is lunelle?

"Lunelle was a shot that was given once a month and was considered to be safe and 97.9-99 percent effective. Some advantages of the shot included that people wouldn't forget to take a pill, it allowed for sexual spontaneity, and periods would be lighter and shorter."

Answered by AI

What is a lunelle?

"The Lunelle contraceptive injection contains medroxyprogesterone acetate and estradiol cypionate, which work together to prevent follicular maturation and ovulation by inhibiting the secretion of gonadotropins. The injection is administered once per month at the recommended dose."

Answered by AI

Is lunelle progestin only?

"Lunelle is a monthly injectable contraceptive that contains estrogen and progestin. It is currently the only injectable contraception available in the United States that is given on a monthly basis."

Answered by AI

Is lunelle still available?

"It Lunelle became available in the United States in 2000. However, due to concern over potency and possible risk of contraceptive failure, the Lunelle syringes were voluntarily recalled in 2002. In October 2003, Pfizer stopped making Lunelle, so it is no longer available in the United States."

Answered by AI

Clinical Trials for Lunelle

Image of Neuromuscular Research Laboratory in Pittsburgh, United States.

Hormone Therapy for Musculoskeletal Health

18 - 40
All Sexes
Pittsburgh, PA

Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps. The goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.

Phase 4
Recruiting

Neuromuscular Research Laboratory

Bradley C Nindl, PhD

Image of University of Colorado Anschutz Medical Campus in Aurora, United States.

Estradiol Patch for Menopause

20 - 45
Female
Aurora, CO

The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen.

Phase 4
Recruiting

University of Colorado Anschutz Medical Campus

Kerrie Moreau, PhD

Image of North Florida/South Georgia Veterans Health System in Gainesville, United States.

Locomotor Training + Testosterone for Spinal Cord Injury

18+
Male
Gainesville, FL

This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.

Phase 2
Recruiting

North Florida/South Georgia Veterans Health System (+1 Sites)

Dana M Otzel, Phd

Have you considered Lunelle clinical trials?

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