Reviewer ’s report  
 
Title:  Norethindrone is superior to combined oral contraceptive pills in short -term delay of 
menses and onset of br eakthrough bleeding: a randomized trial.  
 
Version: 0 Date: 05 Mar 2019 
 
Reviewer:  Inaki  Lete 
 
Reviewer’s report:  
 
This is a randomised clinical trial comparing the effectiveness of norethindrone with that of an 
oral contraceptive in short -term delay of menses and onset of breakthrough bleeding.  
 
The study adds interesting information for the managing of a rather frequent request of patients: 
delaying or avoiding a menstruation.  
 
The article presents an important lack of information the authors have to address before 
accepting it for publication.  
 
1. Being a blinded randomised clinical trial more information about the blinding procedure 
is needed. Who was the responsible of allocation? Who gave the medication packages? 
Were the packages similar or were they as they were branded? How the participants 
doctors were blinded for medication?  
 
2. Reading the material and methods section we do not know how many visits participants 
did. Two? Three? It should be stated in the material and methods section  
 
3. Regarding the table 1 we can see the time to conceive in  both groups. That implies a 
follow -up period that is not shown in the article. Was it? How long was it? How the 
authors obtained information about the pregnancies.  
 
4. Did the authors consider a difference between 2 and 3 months for conception clinically 
relevant? That should be discussed in the text.  
 
5. Authors present the number and percentage of women reporting weight gain. Weight gain 
should be defined, specially in such a study where the treatment period was short.  
 
6. Along the discussion there are sev eral references to LARC methods. LARC methods can 
induce amenorrhea and absence of menstruation but in a longer period of time. Being a 
clinical trial aimed to help women in the short -term to avoid bleeding, the references to 
LARCs should be deleted.  
 
7. There is not a discussion about the strengths and weaknesses of the study. It should be 
compulsory  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include th e necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manuscript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects require further 
assessment in your comments to the editors.  
 
I am able to asses s the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publication of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisati on that may in any way gain or lose 
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the 
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this pape r? 
If you can answer no to all of the above, write 'I declare that I have no competing interests' 
below. If your reply is yes to any, please give details below.  
 
None  
 
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