Clinical trial NCT03594604: Norethindrone for the Delay of Menstruation
Official title: Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menstrual Flow Altered
Keywords: norethindrone
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive oral contraceptive pills or norethindrone
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

* female, age 18-45, regular periods, desires to postpone menstrual period,

Exclusion Criteria:

* fibroids, irregular menstrual cycle, endometrial polyps, BMI\>30

Primary outcomes:
measure: breakthrough bleeding on treatment
timeFrame: at 2 weeks from starting therapy
Secondary outcomes:
measure: Likelihood of recommending this method or using it again
timeFrame: at 2 weeks from starting therapty
measure: Adverse effects
timeFrame: at 2 weeks from starting therapy
Other outcomes:
Locations:
Study officials:
affiliation: St. Vincents Catholic Medical Centers
name: Maurice Recanati
role: PRINCIPAL_INVESTIGATOR
References:
citation: Attia AM, Ibrahim MM, Abou-Setta AM. Role of the levonorgestrel intrauterine system in effective contraception. Patient Prefer Adherence. 2013 Aug 9;7:777-85. doi: 10.2147/PPA.S36948. eCollection 2013.
citation: Yairi-Oron Y, Rabinson J, Orvieto R. A simplified approach to religious infertility. Fertil Steril. 2006 Dec;86(6):1771-2. doi: 10.1016/j.fertnstert.2006.05.050. Epub 2006 Oct 30.
citation: Chertok IR, Zimmerman DR, Taragin S, Silverman Z, Hallak M. Implications of endometriosis for women who observe Jewish law (halakha). Isr Med Assoc J. 2005 Feb;7(2):71-4.
citation: Amy JJ, Tripathi V. Contraception for women: an evidence based overview. BMJ. 2009 Aug 7;339:b2895. doi: 10.1136/bmj.b2895. No abstract available.
citation: Dean J, Kramer KJ, Akbary F, Wade S, Huttemann M, Berman JM, Recanati MA. Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial. BMC Womens Health. 2019 May 28;19(1):70. doi: 10.1186/s12905-019-0766-6.