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Hormone Therapy

Norethindrone Acetate vs. GnRH Agonist for Endometriosis

Q: Could you please compare and contrast previous clinical trials that have studied LD against those studying NA?

As of right now, there are 123 clinical trials ongoing that are investigating LD then NA. Out of those 123 active trials, 42 are in Phase 3. Although the majority of studies for LD then NA originate from Duarte, <a href="https://www.withpower.com/clinical-trials/california">California</a>, there are 7557 locations running trials for this treatment worldwide.

Q: What are the standard applications for LD and NA?

The LD then NA treatment is frequently used to help patients with anger management issues. Additionally, it has been shown to be effective in contraception, female castration, and oral contraceptives cases.

Q: Who would be an ideal candidate for this clinical trial?

This study is currently enrolling 112 participants between the ages of 18 and 55 who suffer from dysmenorrhea. To be eligible, potential subjects must meet the following criteria: They have signed an Informed Consent form after having its contents fully explained to them by a member of the research team; they are pre-menopausal females with regular menstrual cycles (21-42 days apart) who do not experience any menopausal symptoms; they have been diagnosed with <a href="https://www.withpower.com/clinical-trials/endometriosis">endometriosis</a> via laparoscopy or laparotomy and are still symptomatic, AND they have a <a href="https://www.withpower.com/clinical-trials/pain">pain</a> grade of 2 or higher according to Biberoglu's

Q: How many patients are being enrolled in this clinical trial?

As of right now, this study is not looking for new patients. However, it was last updated on October 24th, 2012. If you are interested in other medical trials, there are 121 trials for dysmenorrhea and 123 LD then NA actively enrolling participants.

Q: Are there any available positions for test subjects in this experiment?

Unfortunately, this particular study is no longer recruiting patients. It was initially posted on August 1st, 2004 but the last update was October 24th, 2012. However, there are currently 121 clinical trials actively searching for patients with dysmenorrhea and 123 studies for LD then NA that have open recruitment statuses.

Q: Has the FDA cleared LD and NA for therapeutic use?

LD then NA has received a score of 3 from our team at Power. This is because it is a Phase 3 trial, and thus there is both some evidence of efficacy as well as multiple rounds of safety data supporting this medication.

Q: Can people of legal age participate in this research?

The specific age range for this clinical trial is 18 to 55. There are 23 studies available for minors and 113 trials catered to adults over the age of 65.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 24 weeks of treatment

Awards & highlights

Study Summary

This trial is testing whether norethindrone acetate (NA) is more effective than a GnRH agonist (Lupron-Depot-3) in relieving symptoms of endometriosis, and whether NA has fewer side effects than the GnRH agonist.

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.Check my eligibility

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.See study design

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

Select...

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

Select...

My BMI is under 40.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

To compare the effectiveness of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3) in relieving symptoms of endometriosis

Secondary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,476 Total Patients Enrolled

3 Trials studying Endometriosis

528 Patients Enrolled for Endometriosis

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor

1,963 Previous Clinical Trials

2,674,629 Total Patients Enrolled

15 Trials studying Endometriosis

4,556 Patients Enrolled for Endometriosis

State University of New York - Downstate Medical CenterOTHER

65 Previous Clinical Trials

12,439 Total Patients Enrolled

Media Library

Lupron Depot (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00458458 — Phase 3

Endometriosis Research Study Groups: LD then NA, NA alone

Endometriosis Clinical Trial 2023: Lupron Depot Highlights & Side Effects. Trial Name: NCT00458458 — Phase 3

Lupron Depot (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00458458 — Phase 3

Frequently Asked Questions

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

Could you please compare and contrast previous clinical trials that have studied LD against those studying NA?

"As of right now, there are 123 clinical trials ongoing that are investigating LD then NA. Out of those 123 active trials, 42 are in Phase 3. Although the majority of studies for LD then NA originate from Duarte, California, there are 7557 locations running trials for this treatment worldwide."

Answered by AI

What are the standard applications for LD and NA?

"The LD then NA treatment is frequently used to help patients with anger management issues. Additionally, it has been shown to be effective in contraception, female castration, and oral contraceptives cases."

Answered by AI

Who would be an ideal candidate for this clinical trial?

"This study is currently enrolling 112 participants between the ages of 18 and 55 who suffer from dysmenorrhea. To be eligible, potential subjects must meet the following criteria: They have signed an Informed Consent form after having its contents fully explained to them by a member of the research team; they are pre-menopausal females with regular menstrual cycles (21-42 days apart) who do not experience any menopausal symptoms; they have been diagnosed with endometriosis via laparoscopy or laparotomy and are still symptomatic, AND they have a pain grade of 2 or higher according to Biberoglu's"

Answered by AI

How many patients are being enrolled in this clinical trial?

"As of right now, this study is not looking for new patients. However, it was last updated on October 24th, 2012. If you are interested in other medical trials, there are 121 trials for dysmenorrhea and 123 LD then NA actively enrolling participants."

Answered by AI

Are there any available positions for test subjects in this experiment?

"Unfortunately, this particular study is no longer recruiting patients. It was initially posted on August 1st, 2004 but the last update was October 24th, 2012. However, there are currently 121 clinical trials actively searching for patients with dysmenorrhea and 123 studies for LD then NA that have open recruitment statuses."

Answered by AI

Has the FDA cleared LD and NA for therapeutic use?

"LD then NA has received a score of 3 from our team at Power. This is because it is a Phase 3 trial, and thus there is both some evidence of efficacy as well as multiple rounds of safety data supporting this medication."

Answered by AI

Can people of legal age participate in this research?

"The specific age range for this clinical trial is 18 to 55. There are 23 studies available for minors and 113 trials catered to adults over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg)

Ozgul Muneyyirci-Delale 2004. "Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00458458.

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