Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-29 @ 4:16 AM
Study NCT ID:
NCT03594604
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2018-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norethindrone for the Delay of Menstruation
Sponsor:
Wayne State University
Organization:
Study Overview
Official Title:
Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of oral contraceptive pills versus norethindrone to delay menstuation.
Detailed Description:
Many women ask the OBGYN for help in delaying a poorly timed period in order to participate in events that menstruation would normally interfere with. While most OBGYNs prescribe combined oral contraceptives for this purpose, this method often results in unpredictable spotting, especially at the beginning of therapy. Norethindrone, a progesterone agonist, inhibits ovulation through its antagonistic effect at the anterior pituitary, preventing the release of LH. Additionally, it thickens cervical mucus to inhibit sperm migration into the uterine cavity . Norethindrone downregulates estrogen receptors on the endometrium lining preventing endometrial proliferation, enhancing glandular secretion, and maintaining endometrium integrity. Therefore, norethindrone is well suited in preventing the endometrium from breakdown and preventing menstrual bleeding. Indeed, many OBGYNs have consistently used it for this purpose in women who desire to remain fertile. The intention of our study was to compare norethindrone to birth control pills in order to determine the effectiveness at suppressing bleeding and spotting, compare side effect profiles and to find a method allowing women to freely and comfortably participate in their life events.
OBJECTIVES:
1. Determine if norethindrone can delay menstruation without breakthrough bleeding
2. Compare norethindrone with oral contraceptive pills for delaying menstruation
3. Compare patient satisfaction of each method
4. Compare side effect profiles of each method
OBJECTIVES:
1. Determine if norethindrone can delay menstruation without breakthrough bleeding
2. Compare norethindrone with oral contraceptive pills for delaying menstruation
3. Compare patient satisfaction of each method
4. Compare side effect profiles of each method
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: