What side effects are associated with this type of intervention?

Norethindrone Acetate, a progestin, is commonly associated with side effects such as weight gain, bloating, mood changes, and breakthrough bleeding. It generally does not affect bone density. GnRH agonists, which suppress ovarian hormone production, can lead to menopausal symptoms like hot flashes, night sweats, vaginal dryness, and decreased libido. Long-term use of GnRH agonists is also associated with bone density loss, which can increase the risk of osteoporosis. Both treatments aim to reduce endometriosis-related pain but come with their respective side effect profiles that should be considered in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis, including progestins and GnRH agonists. Norethindrone acetate, a progestin, is used to suppress the growth of endometrial tissue and alleviate symptoms. GnRH agonists, such as leuprolide (Lupron Depot), work by suppressing ovarian hormone production, leading to a decrease in endometrial tissue growth and associated pain. These treatments are effective in managing endometriosis symptoms, although they may have different side effect profiles and long-term implications.

What other types of research exist?

Promising novel alternatives for endometriosis treatment include Dienogest, which has been shown to reduce endometrioma recurrence and preserve ovarian function, and aromatase inhibitors like Letrozole, which can be combined with other medications to effectively manage pain symptoms. Additionally, extended-cycle oral contraceptives and Levonorgestrel-releasing intrauterine devices (LNG-IUDs) are also being explored for their potential benefits in symptom management and recurrence prevention.

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Hormone Therapy

Norethindrone Acetate vs. GnRH Agonist for Endometriosis

Q: What is the mechanism of action of this treatment?

Norethindrone Acetate (NA) is a progestin that works by suppressing the growth of endometrial tissue, which helps reduce pain and other symptoms associated with endometriosis. It achieves this by creating a hormonal environment that is less conducive to the proliferation of endometrial cells. GnRH Agonists, such as Lupron Depot, suppress ovarian hormone production by initially stimulating and then downregulating the release of gonadotropins, leading to a decrease in estrogen levels. This reduction in estrogen helps to shrink endometrial tissue and alleviate symptoms. These treatments are crucial for endometriosis patients as they target the hormonal imbalances that drive the disease, thereby providing symptom relief and potentially slowing disease progression.

Phase 3

Waitlist Available

Led By Ozgul Muneyyirci-Delale, M.D.

Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subject is a pre-menopausal female at least 18 years of age at the time of screening having regular periods (21-42 days intervals) with no menopausal symptoms.

Less than grade III overweight or BMI <40 kg/M2

Must not have

Subject has a bone density T score less or equal to 2.5, history of nontraumatic fracture, history of spinal surgery, history of fusion of lumbar region, history of severe scoliosis greater than 20 degrees.

A previous history of significant adverse reactions to hormone, progestin or progesterone and GnRH agonist therapies.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment and follow-up

Awards & highlights

Approved for 5 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial compares two treatments for women with painful endometriosis. One treatment is a hormone pill, and the other is an injection. Both aim to reduce tissue growth and pain by changing hormone levels.

Who is the study for?

This trial is for pre-menopausal women over 18 with regular periods and diagnosed endometriosis, confirmed by surgery. They should be in good health, not have used certain hormone therapies recently, and agree to use double-barrier contraception. Women who are postpartum or lactating within the last 3 months, have significant abnormal lab results or Pap smears, low bone density, or a history of severe reactions to hormones are excluded.

What is being tested?

The study compares Norethindrone Acetate (NA) with GnRH Agonist (Lupron Depot) in treating endometriosis symptoms. It aims to see if NA maintains bone density better than Lupron Depot while also assessing effects on lipid profiles and quality of life through questionnaires.

What are the potential side effects?

Potential side effects include changes in menstrual cycle patterns, mood swings, weight gain for NA; and hot flashes, headaches, sleep problems for Lupron Depot. Both may affect bone density and sexual function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a pre-menopausal woman over 18 with regular periods and no menopause symptoms.

Select...

My BMI is under 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have low bone density or a history of specific bone issues.

Select...

I've had severe side effects from hormone or GnRH treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare effect of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3)on bone density

Secondary study objectives

To compare the effect of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3)on lipid profiles

To determine the effect treatment has on quality of life

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: LD then NAActive Control1 Intervention

Lupron Depot(LD) given intramuscularly every 12 weeks for total of 24 weeks then switched to Norethindrone Acetate (NA) taken 1-3 tablets orally every night for remainder of treatment

Group II: NA aloneActive Control1 Intervention

Norethindrone Acetate (NA) 5mg taken 1-3 tabs orally every night for duration of treatment

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Norethindrone Acetate (NA) is a progestin that works by suppressing the growth of endometrial tissue, which helps reduce pain and other symptoms associated with endometriosis. It achieves this by creating a hormonal environment that is less conducive to the proliferation of endometrial cells. GnRH Agonists, such as Lupron Depot, suppress ovarian hormone production by initially stimulating and then downregulating the release of gonadotropins, leading to a decrease in estrogen levels. This reduction in estrogen helps to shrink endometrial tissue and alleviate symptoms. These treatments are crucial for endometriosis patients as they target the hormonal imbalances that drive the disease, thereby providing symptom relief and potentially slowing disease progression.