Ethical considerations and trial registration
COA
The trial was approved by the University of Health and Allied Sciences, Research Ethics Committee with protocol number UHAS-REC A. 2(4) 20 -2. It has been registered with the Pan African Clinical Trials Registry on 18/11/2020 with the unique identification number PACTR202011687956222 and the Food and Drugs Authority (FDA) Ghana Clinical Trials Registry with certificate number FDA/CT/217. The investigational product (shea lubricant) underwent physiochemical and microbiological analysis at the Ghana Standards Authority. The certificate of analysis (COA) of the control lubricant was similarly verified by FDA, Ghana. The trial was conducted according to the declaration of Helsinki and trial participants gave written informed consent before enrollment. The study protocol further outlines the rationale, design and methods of the trial