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Norethindrone for the Delay of Menstruation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594604
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Maurice-Andre Recanati, Wayne State University

Brief Summary:
Comparison of oral contraceptive pills versus norethindrone to delay menstuation.

Condition or disease Intervention/treatment Phase
Menstrual Flow Altered Drug: Norethindrone Drug: oral contraceptive pill Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive oral contraceptive pills or norethindrone
Masking: Single (Investigator)
Masking Description: Patients will be randomized to receive oral contraceptive pills or norethindrone
Primary Purpose: Prevention
Official Title: Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation
Actual Study Start Date : June 15, 2007
Actual Primary Completion Date : December 15, 2007
Actual Study Completion Date : December 15, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arm Intervention/treatment
Experimental: Norethindrone
Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons.
Drug: Norethindrone
Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.
Other Name: (Aygestin)

Active Comparator: Oral Contraceptive Pills
Women who desire postponing their periods are typically treated with oral contraceptive pills, the current standard of care.
Drug: oral contraceptive pill
Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.
Other Name: Combined oral contraceptive pill




Primary Outcome Measures :
  1. breakthrough bleeding on treatment [ Time Frame: at 2 weeks from starting therapy ]
    comparison of breakthrough bleeding between oral contraceptives and norethindrone


Secondary Outcome Measures :
  1. Likelihood of recommending this method or using it again [ Time Frame: at 2 weeks from starting therapty ]
    A questionnaire given to the patient at 2 weeks from starting therapy and containing the question "on a scale from 1-5 (5 most likely) how likely are you to recommend this method to a friend or using it again yourself".

  2. Adverse effects [ Time Frame: at 2 weeks from starting therapy ]
    measurement of side effects from norethindrone therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females menstruate
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594604


Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Maurice Recanati St. Vincents Catholic Medical Centers
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maurice-Andre Recanati, Assistant Professor, Clinical Educator, Wayne State University
ClinicalTrials.gov Identifier: NCT03594604    
Other Study ID Numbers: 040818M1
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maurice-Andre Recanati, Wayne State University:
norethindrone
Additional relevant MeSH terms:
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Contraceptive Agents
Norethindrone
Norethindrone Acetate
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic