Norethindrone for the Delay of Menstruation

NCT03594604 | Completed Phase 4 FDA Drug

• 1 other identifier: 040818M1
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison of oral contraceptive pills versus norethindrone to delay menstuation.

Conditions

Menstrual Flow Altered

Keywords

norethindrone

Outcome Measures

Primary Outcomes (1)

• breakthrough bleeding on treatment

  comparison of breakthrough bleeding between oral contraceptives and norethindrone

  at 2 weeks from starting therapy

Secondary Outcomes (2)

• Likelihood of recommending this method or using it again

  at 2 weeks from starting therapty

• Adverse effects

  at 2 weeks from starting therapy

Study Arms (2)

Norethindrone

EXPERIMENTAL

Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons.

Drug: Norethindrone

Oral Contraceptive Pills

ACTIVE COMPARATOR

Women who desire postponing their periods are typically treated with oral contraceptive pills, the current standard of care.

Drug: oral contraceptive pill

Interventions

Norethindrone DRUG

Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.

Also known as: (Aygestin)

Norethindrone

oral contraceptive pill DRUG

Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.

Also known as: Combined oral contraceptive pill

Oral Contraceptive Pills

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only females menstruate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wayne State University: lead

Related Publications (5)

• 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.

  PMID: 23990713 BACKGROUND

• 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.

  PMID: 17074351 RESULT

• 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.

  PMID: 15729953 RESULT

• 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.

  PMID: 19666684 RESULT

• 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.

  PMID: 31138184 DERIVED

MeSH Terms

Interventions

Norethindrone; Norethindrone Acetate; Contraceptives, Oral; Contraceptives, Oral, Combined

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Maurice Recanati

  St. Vincents Catholic Medical Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients will be randomized to receive oral contraceptive pills or norethindrone
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Clinical Educator

Model Details: Patients will be randomized to receive oral contraceptive pills or norethindrone

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 20, 2018
• Study Start: June 15, 2007
• Primary Completion: December 15, 2007
• Study Completion: December 15, 2007
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share