NCT05294341 is a Phase 4 clinical trial of Norethindrone Acetate 5 MG in Contraception, sponsored by Milton S. Hershey Medical Center.

Who is sponsoring NCT05294341?

NCT05294341 is sponsored by Milton S. Hershey Medical Center.

What drugs are being tested in NCT05294341?

Interventions in NCT05294341: Norethindrone Acetate 5 MG, Norethindrone 0.35 MG.

What condition does NCT05294341 study?

NCT05294341 studies Contraception.

Is NCT05294341 still recruiting?

NCT05294341 is currently completed. Last updated 16 July 2024.

Are results published for NCT05294341?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-16 · How we verify

NCT05294341

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate

Completed Phase 4 Results posted Last updated 16 July 2024

What this trial tests

Phase 4 trial testing Norethindrone Acetate 5 MG in Contraception in 6 participants. Completed in 1 May 2023.

Timeline

22 July 2022

Primary endpoint
1 May 2023

1 May 2023

Quick facts

Lead sponsor	Milton S. Hershey Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	6
Start date	22 July 2022
Primary completion	1 May 2023
Estimated completion	1 May 2023
Sites	1 location across United States

Drugs / interventions tested

Norethindrone Acetate 5 MG — full drug profile →
Norethindrone 0.35 MG — full drug profile →

Conditions studied

Contraception — all drugs for Contraception →

Sponsor

Milton S. Hershey Medical Center

Who can join

Adults 18 to 55, female only, with Contraception. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Serum Concentration of Norethindrone Primary · Day 1-7

The change in serum concentration of norethindrone in individuals taking 0.35mg norethindrone and 5mg norethindrone acetate will be assessed daily over one week of medication use. Norethindrone levels are then averaged across all subjects teaching each medication in each sequence for days 1-7.

Day 1

Group	Value	95% CI
5mg Norethindrone Acetate	15.69	± 8.6
0.35mg Norethindrone	2.28	± 1.878562984

Day 2

Group	Value	95% CI
5mg Norethindrone Acetate	13.56	± 8.695089814
0.35mg Norethindrone	2.50	± 2.02

Day 3

Group	Value	95% CI
5mg Norethindrone Acetate	13.96	± 9.767023293
0.35mg Norethindrone	2.28	± 1.28

Day 4

Group	Value	95% CI
5mg Norethindrone Acetate	16.56	± 9.173183846
0.35mg Norethindrone	2.42	± 1.08

Day 5

Group	Value	95% CI
5mg Norethindrone Acetate	11.82	± 9.173183846
0.35mg Norethindrone	2.22	± 1.65

Day 6

Group	Value	95% CI
5mg Norethindrone Acetate	18.92	± 8.652213867
0.35mg Norethindrone	2.82	± 1.65

Day 7

Group	Value	95% CI
5mg Norethindrone Acetate	11.30	± 6.505930925
0.35mg Norethindrone	2.22	± 1.30

Day 8 Norethindrone Levels Secondary · Hourly for eight hours on Day 8

The change in serum concentration of norethindrone in individuals taking 0.35mg norethindrone and 5mg norethindrone acetate will be assessed hourly for 8 hours in the absence of exposure to either medication. This is represented as a rate of decline.

Hour 0

Group	Value	95% CI
5mg Norethindrone Acetate	1.54	± 0.583608153
0.35mg Norethindrone	0.14729	± 0.07215209

Hour 1

Group	Value	95% CI
5mg Norethindrone Acetate	1.17	± 0.389190923
0.35mg Norethindrone	0.129893333	± 0.079030195

Hour 2

Group	Value	95% CI
5mg Norethindrone Acetate	1.31	± 0.451133779
0.35mg Norethindrone	0.149843333	± 0.071421545

Hour 3

Group	Value	95% CI
5mg Norethindrone Acetate	1.29	± 0.535815038
0.35mg Norethindrone	0.112873333	± 0.076

Hour 4

Group	Value	95% CI
5mg Norethindrone Acetate	1.13	± 0.480888744
0.35mg Norethindrone	0.11	± 0.084

Hour 5

Group	Value	95% CI
5mg Norethindrone Acetate	1.04	± 0.367513739
0.35mg Norethindrone	0.11041	± 0.11041

Hour 6

Group	Value	95% CI
5mg Norethindrone Acetate	0.99	± 0.38615963
0.35mg Norethindrone	0.096743333	± 0.067140596

Hour 7

Group	Value	95% CI
5mg Norethindrone Acetate	1.0	± 0.433300735
0.35mg Norethindrone	0.090736667	± 0.0645776

Differences of Serum Levels of Estradiol, Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Progesterone Secondary · Day 1 and Day 21

The serum levels of estradiol, LH, FSH, and progesterone will be compared in individuals taking 0.35mg norethindrone and 5mg norethindrone acetate at study start and on Day 21

Estradiol Day 1

Group	Value	95% CI
5mg Norethindrone Acetate	34.7	± 9.44
0.35mg Norethindrone	33.5	± 7.8

Estradiol Day 21

Group	Value	95% CI
5mg Norethindrone Acetate	147	± 176
0.35mg Norethindrone	139	± 56.45

Progesterone Day 1

Group	Value	95% CI
5mg Norethindrone Acetate	0.45	± 0.19
0.35mg Norethindrone	0.44	± 0.16

Progesterone Day 21

Group	Value	95% CI
5mg Norethindrone Acetate	0.95	± 0.97
0.35mg Norethindrone	11.6	± 3.72

LH Day 1

Group	Value	95% CI
5mg Norethindrone Acetate	6.73	± 1.56
0.35mg Norethindrone	7.4	± 1.4

LH Day 21

Group	Value	95% CI
5mg Norethindrone Acetate	11.8	± 9.7
0.35mg Norethindrone	6.65	± 5.37

FSH Day 1

Group	Value	95% CI
5mg Norethindrone Acetate	8.73	± 3.5
0.35mg Norethindrone	8.53	± 3.2

FSH Day 21

Group	Value	95% CI
5mg Norethindrone Acetate	6.7	± 3.1
0.35mg Norethindrone	2.75	± 0.3

Sponsor's own description

0.35mg norethindrone, also known as progesterone only pills, are routinely prescribed as immediate postpartum oral contraception. Norethindrone acetate is prescribed for gynecologic indications, but has never been studied as an efficacious form of contraception. This is a pilot crossover study examining the pharmacokinetics of norethindrone, the metabolically active component of both drugs, in participants taking 5mg norethindrone and 0.35mg norethindrone acetate.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Contraception

Currently open trials in the same condition.

NCT07365904 — Investigating Ovulation Inhibition for Use as a Contraceptive · Phase 2 · recruiting
NCT07437495 — Women's Knowledge of Contraception During the Postpartum Period · active not recruiting
NCT06823037 — Hormonal Contraception Access Through Pharmacist Prescribing Implementation · NA · recruiting
NCT07326007 — Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women W · NA · recruiting
NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years · NA · recruiting

Other Milton S. Hershey Medical Center trials

Trials by the same sponsor.

NCT05180552 — The HEALiX: Comparing the Efficacy of the HEALiX Device With Wrist Restraints in a Critical Care Setting · NA · withdrawn
NCT07461844 — Transdiagnostic Sleep and Circadian Treatment for Autistic Adults · NA · not yet recruiting
NCT06253858 — Ultrasound (US) Guided External Ventricular Catheter Placement · NA · not yet recruiting
NCT07225699 — IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING · NA · not yet recruiting
NCT07461168 — Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the Emergency Department · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05294341 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Milton S. Hershey Medical Center
Last refreshed: 16 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05294341.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing