Menstrual Flow AlteredPhase 4NCT03594604
Norethindrone for the Delay of Menstruation
A Phase 4 study testing Norethindrone and oral contraceptive pill in people with Menstrual Flow Altered, run by Wayne State University.
Trial summary
Comparison of oral contraceptive pills versus norethindrone to delay menstuation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Flow Altered
- What is being tested?
- Norethindrone and oral contraceptive pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2007to 15 Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female, age 18-45, regular periods, desires to postpone menstrual period,
Who cannot join
- fibroids, irregular menstrual cycle, endometrial polyps, BMI>30
About this study
Official title: Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation
Comparison of oral contraceptive pills versus norethindrone to delay menstuation.
Read the 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:
- Determine if norethindrone can delay menstruation without breakthrough bleeding
- Compare norethindrone with oral contraceptive pills for delaying menstruation
- Compare patient satisfaction of each method
- Compare side effect profiles of each method
- Conditions
- Menstrual Flow Altered
- Being tested
- Norethindrone, oral contraceptive pill
- Keywords
- norethindrone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorethindroneDrug
Also called (Aygestin)
Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.
oral contraceptive pillDrug
Also called Combined oral contraceptive pill
Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.
| Study group | Role | What they receive |
|---|---|---|
| Norethindrone | Experimental | Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons. Receives: 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. Receives: Drug: oral contraceptive pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
breakthrough bleeding on treatment
comparison of breakthrough bleeding between oral contraceptives and norethindrone
Measured: at 2 weeks from starting therapy
Secondary outcomes (2)
Likelihood of recommending this method or using it again
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".
Measured: at 2 weeks from starting therapty
Adverse effects
measurement of side effects from norethindrone therapy
Measured: at 2 weeks from starting therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start15 Jun 2007
- Primary completion15 Dec 2007
- Study completion15 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Menstrual Flow AlteredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive oral contraceptive pills or norethindrone
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurice-Andre Recanati, Wayne State University
- Investigators
- Maurice Recanati, Principal investigator, St. Vincents Catholic Medical Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594604
- Sponsor's protocol ID
- 040818M1
- Status last verified
- Jul 2018
- First submitted
- 18 Jun 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23990713Yairi-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.
PubMed 17074351Chertok 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.
PubMed 15729953Amy JJ, Tripathi V. Contraception for women: an evidence based overview. BMJ. 2009 Aug 7;339:b2895. doi: 10.1136/bmj.b2895. No abstract available.
PubMed 19666684Dean 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.
PubMed 31138184
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation
- ClinicalTrials.gov ID
- NCT03594604
- Acronym / sponsor ID
- 040818M1
- Conditions
- Menstrual Flow Altered
- Keywords
- norethindrone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 15 Jun 2007 (actual)
- Primary completion
- 15 Dec 2007 (actual)
- Study completion
- 15 Dec 2007 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine if norethindrone can delay menstruation without breakthrough bleeding
- Compare norethindrone with oral contraceptive pills for delaying menstruation
- Compare patient satisfaction of each method
- Compare side effect profiles of each method
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive oral contraceptive pills or norethindrone
| Arm | Type | Receives |
|---|---|---|
| Norethindrone | Experimental | Drug: NorethindroneDelaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons. |
| Oral Contraceptive Pills | Active comparator | Drug: oral contraceptive pillWomen who desire postponing their periods are typically treated with oral contraceptive pills, the current standard of care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female, age 18-45, regular periods, desires to postpone menstrual period,
Key exclusion criteria (1 listed)
- fibroids, irregular menstrual cycle, endometrial polyps, BMI>30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorethindroneAlso: (Aygestin)Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily. | Drug | Norethindrone |
| oral contraceptive pillAlso: Combined oral contraceptive pillWomen desiring to postpone their periods may be randomized to daily oral contraceptive pills. | Drug | Oral Contraceptive Pills |
Primary outcome
breakthrough bleeding on treatment
Time frame: at 2 weeks from starting therapy
comparison of breakthrough bleeding between oral contraceptives and norethindrone
2 secondary outcomes
Likelihood of recommending this method or using it again
Time frame: at 2 weeks from starting therapty
Adverse effects
Time frame: at 2 weeks from starting therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Background: PubMed 23990713Attia 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.
- Results publication: PubMed 17074351Yairi-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.
- Results publication: PubMed 15729953Chertok 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.
- Results publication: PubMed 19666684Amy JJ, Tripathi V. Contraception for women: an evidence based overview. BMJ. 2009 Aug 7;339:b2895. doi: 10.1136/bmj.b2895. No abstract available.
- Derived from this study: PubMed 31138184Dean 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Recanati principal investigator
St. Vincents Catholic Medical Centers
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norethindrone and oral contraceptive pill in people with Menstrual Flow Altered, run by Wayne State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breakthrough bleeding on treatment (time frame: at 2 weeks from starting therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594604, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.