NCT03594604

Norethindrone for the Delay of Menstruation

Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Menstrual Flow Altered

Interventions

Type	Name	Description
DRUG	Norethindrone	Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.
DRUG	oral contraceptive pill	Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.

Timeline

• Start date: 2007-06-15
• Primary completion: 2007-12-15
• Completion: 2007-12-15
• First posted: 2018-07-20
• Last updated: 2018-07-20

Regulatory

• FDA-regulated drug study