Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609809175173 Date of Registration: 11/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Long-acting User-friendly Novel Approaches for HMB management.
Official scientific title Phase 1 (placebo only) cross-over trial to assess acceptability, safety, and usability of two prototype placebo vaginal films among women with and without heavy menstrual bleeding in South Africa.
Brief summary describing the background and objectives of the trial Heavy Menstrual Bleeding (HMB) affects about 20% of women worldwide, with even higher rates in low and middle income countries. It is defined as menstrual blood loss over 80 mL per cycle or bleeding lasting more than seven days. HMB has significant physical, emotional, and social effects on the affected individuals. Levonorgestrel (LNG), a synthetic progestogen used in emergency contraception and in hormonal IUDs which are approved for treating HMB. These IUDs work by continuously releasing LNG to thin the uterine lining, alter blood vessel structure, reduce menstrual flow, and decrease uterine contractions providing both therapeutic and contraceptive benefits. However, hormonal IUD use in LMICs remains low due to cost, access challenges, myths, provider dependency, and concerns about safety and reversibility. Vaginal films offer an alternative: they are low cost, discreet, self administered, and do not require healthcare provider involvement or special storage. A one month LNG vaginal film could therefore be a promising option for African women seeking both HMB management and pregnancy prevention. The study described aims to develop and evaluate an LNG vaginal film as an accessible self care product for women in LMICs. Initial work will test placebo films in South African women to assess acceptability and safety. Findings from usability testing, lab data, and clinical insights will inform selection of a lead formulation for further development. Overall, the project integrates pharmaceutical and socio behavioral research to build evidence for a new self administered product that could expand contraceptive and menstrual health options for underserved populations.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LUNA
Disease(s) or condition(s) being studied Haematological Disorders,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2026
Actual trial start date
Anticipated date of last follow up 01/06/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
DOH-27-092026-7768 SANCTR
AWD00011831 202965-1 Gates Foundation
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation Sequence/Code was not concealed Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group LUNA Placebo Vaginal Film A The products being used in this study are the placebo prototype vaginal films A and B. The two films are soft and flexible with rounded edges and differ from each other by different mechanical properties and mucoadhesion. Participants will be randomized (1:1) to use two placebo films in either sequence A to B or B to A. Film use will occur in sequential order and will involve a single application of each film and monitoring for one month with a non-use period of approximately 7 to 14 days (1-2 weeks) in between. Films should not be inserted during menses. Film use will occur in sequential order and will involve a single application of each film and monitoring for one month with a non-use period of approximately 7 to 14 days (1-2 weeks) in between. Appearance is Flat, flexible, translucent to off-white film, with 110-150 μm thickness. Weighs 350-430 mg, with not more than 15% w/w water content. Microbial testing is not more than 100 CFU/g, Total Aerobic Microbial Count Not more than 10 CFU/g, Total Yeast/Mold Counts. Absence of the following: 1. Pseudomonas aeruginosa 2. Staphylococcus aureus 3. Candida albicans 20
Experimental Group LUNA Placebo Vaginal Film B Participants will be randomized (1:1) to use two placebo films in either sequence A to B or B to A. Film use will occur in sequential order and will involve a single application of each film and monitoring for one month with a non-use period of approximately 7 to 14 days (1-2 weeks) in between. 1 month Appearance is Flat, flexible, translucent to off-white film, with 110-150 μm thickness. Weighs 326-440 mg, with not more than 15% w/w water content. Microbial testing is not more than 100 CFU/g, Total Aerobic Microbial Count Not more than 10 CFU/g, Total Yeast/Mold Counts. Absence of the following: 1. Pseudomonas aeruginosa 2. Staphylococcus aureus 3. Candida albicans 20
Control Group Not Applicable Not Applicable Not Applicable Not Applicable 0 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Potential participants 1) Cisgender women aged 18 to 45 years (inclusive and reproductive age) at Screening, verified per site SOP. 2) Should be past sexual debut and either sexually active or abstinent 3) Should have had regular menstrual cycles for the past three months 4) Assigned female sex at birth. 5) Able and willing to provide written informed consent to be screened for and enrolled in LUNA in one of the study languages (IsiZulu and English). 6) Able and willing to provide adequate contact/locator information, as defined in site SOP. 7) Able and willing to comply with all protocol requirements 8) HIV-uninfected based on testing performed at Screening and Enrollment 9) Negative urine pregnancy test at Screening and Enrollment. 10) History of regular menstrual cycles (typically 21–35 days). 11) Willing to assess menstrual cycle for presence of HMB using an HMB screening tool –SAMANTA (16, 17) 12) If assessed to have HMB, must be willing to receive counselling and, where clinically indicated, access non-hormonal HMB treatment or referral according to local standard of care 13) Willing to use the placebo vaginal film 14) Participants must have documentation of a Grade 0 Pap smear within the past 3 years prior to Enrollment, or a Grade 0 or Grade 1 Pap smear at Screening with no treatment required,PAP smears will be performed for participants where documentation of a normal Pap test within 3 years prior to enrolment, is unavailable. 15) Be protected from pregnancy by an effective contraceptive method for the duration of study participation 16) Willing to be audio-recorded Inclusion Criteria for the HCP FGD 1)Provides sexual and reproductive health services to women (including HMB management) 3) Able and willing to provide written informed consent to participate in LUNA in one of the study languages 4) Able and willing to provide adequate contact/locator information 5) Able and Willing to contribute to FGD Discussion and willing to be audio recorded Potential participants 1) Per participant report at Screening and Enrollment, intends to do any of the following during the study participation period: • Become pregnant • Breastfeed • Relocate away from the study site • Travel away from the study site for a time period that would interfere with product insertion and/or study participation. 2) Positive HIV test at Screening or Enrollment. 3) Diagnosed with a sexually transmitted infection (STI), urinary tract infection (UTI), pelvic inflammatory disease (PID), or reproductive tract infection (RTI) 4) Clinically apparent Grade 2 or higher pelvic exam finding per the DAIDS Table for Grading Adult and Pediatric Adverse Events, 5) Participant report and/or clinical evidence of any of the following: • Known adverse reaction to any of the study product materials (ever). • Hysterectomy. • Surgical procedure involving the pelvis in the 30 days prior to Enrollment. • Use of diaphragm, NuvaRing, or spermicide for contraception in the two weeks prior to Screening. • Antibioticor antifungal (oral or intravaginal) therapy within 7 days of Enrollment. • Prior use of post-exposure prophylaxis (PEP). • Use of any of the following in the 12 months prior to Screening: stimulants (cocaine [including crack], methamphetamine, or non-physician prescribed pharmaceutical-grade stimulants), or inhaled nitrates, or illicit injection drug use of any kind • At Screening or Enrollment, as determined by PI/designee, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease. 6) Menses like bleeding at the time of enrollment: Note: enrollment can be rescheduled if still within the 30-day enrollment window. 7) Has any of the following laboratory abnormalities at Screening: • Grade 3 or higher Hemoglobin Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/08/2026 University of Witwatersrand Human Research Ethics Committee Wits HREC
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Corner York Road, and 29 Princess of Wales Terrace, Parktown, 2193 Johannesburg 2193 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/07/2026 SAHPRA
Ethics Committee Address
Street address City Postal code Country
SAHPRA Head Office, Building A, Loftus Park, 2nd Floor, 402 Kirkness Street, Arcadia, 0083 Pretoria 0083 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary objectives: Acceptability - To assess acceptability of two placebo prototype films when administered vaginally once monthly Primary endpoints: Acceptability - Proportion of participants rating overall satisfaction with using the placebo vaginal films as assessed on a Likert scale from 1 (extremely dissatisfied) to 10 (extremely satisfied). Visit 7
Secondary Outcome Secondary objectives: Safety - To assess the safety of two placebo prototype vaginal films when administered vaginally once monthly Usability - To assess participants’ ability to properly insert the placebo vaginal films visit 1-visit 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wits RHI Research Centre Clinical Research Site 07 Esselen Street, Hillbrow Johannesburg 2038 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Gates Foundation 500 5th Ave North Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gates Foundation 500 5th Ave North Seattle 98109 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Lisa Rohan Department of Pharmaceutical Sciences University of Pittsburgh School of Pharmacy Magee-Womens Research Institute 204 Craft Avenue Pittsburgh 15213 United States of America
Junmei Zhang Department of Obstetrics, Gynecology, and Reproductive Sciences University of Pittsburgh School of Medicine Magee-Womens Research Institute 204 Craft Avenue Pittsburgh 15213 United States of America
Sravan Kumar Patel Department of Pharmaceutical Sciences University of Pittsburgh School of Pharmacy Magee-Womens Research Institute 204 Craft Avenue Pittsburgh 15213 United States of America
Zikhona Njengele Tetyana Wits RHI Research Centre CRS 7 Esselen Street, 3rd-5th Floors Hillbrow Johannesburg 2038 South Africa
Thabile Mahlangu Wits RHI Research Centre CRS 7 Esselen Street, 3rd-5th Floors Hillbrow Johannesburg 2038 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Thesla PalaneePhillips tpalanee@wrhi.ac.za +27113585471 Wits RHI Research Centre CRS 7 Esselen Street, 3rd-5th Floors Hillbrow, Johannesburg South Africa, 2038
City Postal code Country Position/Affiliation
Johannesburg 2038 South Africa Director
Role Name Email Phone Street address
Principal Investigator Lisa Rohan lrohan@mwri.magee.edu +14126416108 Department of Pharmaceutical Sciences University of Pittsburgh School of Pharmacy Magee-Womens Research Institute 204 Craft Avenue Pittsburgh, PA 15213 USA
City Postal code Country Position/Affiliation
Pittsburgh 15213 United States of America Principal Investigator
Role Name Email Phone Street address
Public Enquiries Krishnaveni Reddy kreddy@wrhi.ac.za +27113585470 Wits RHI Research Centre CRS 7 Esselen Street, 3rd-5th Floors Hillbrow, Johannesburg South Africa, 2038
City Postal code Country Position/Affiliation
Johannesburg 2038 South Africa Technical Head
Role Name Email Phone Street address
Scientific Enquiries Nkosiphile Ndlovu nkndlovu@wrhi.ac.za +27847225877 Wits RHI Research Centre CRS 7 Esselen Street, 3rd-5th Floors Hillbrow, Johannesburg South Africa, 2038
City Postal code Country Position/Affiliation
Johannesburg 2038 South Africa Senior Research Clinician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All institutions and organizations affiliated with the LUNA Study will comply with the Protection of Personal Information Act (POPIA) and its Regulations in handling participants’ personal information. POPIA requires that personal information be collected, processed, stored, and shared responsibly, with accountability in the event of misuse or compromise. Individual participant data (IPD) may be accessed by individuals or entities outside the immediate study team where necessary for the conduct, oversight, or verification of the study (e.g., regulatory authorities, ethics committees, or authorized collaborators). Such access will be limited to what is necessary and handled in accordance with POPIA requirements. Authorization from participants is required for the use and disclosure of their personal information. Participation in the study is contingent upon providing this authorization. Participants may withdraw their authorization at any time by notifying the Principal Investigator; however, doing so will result in withdrawal from the study, and no further data will be collected. Withdrawal will not affect the use of data already collected or previously shared. There is no predefined time limit for the retention and use of study data, subject to applicable legal and regulatory requirements. Participants have the right to request access to, correction of, or limitations on the use of their personal information, particularly where inaccuracies are identified. Complaints regarding the use of personal information may be directed to the South African Information Regulator (https://inforegulator.org.za/complaints/; email: POPIAComplaints@inforegulator.org.za or enquiries@inforegulator.org.za) or to the Deputy Information Officer of Wits Health Consortium (Pty) Ltd (email: popia@witshealth.co.za). Informed Consent Form,Study Protocol There is no fixed time limit for the use, retention, or sharing of individual participant data. Data may be retained and shared for as long as necessary to fulfill the scientific, regulatory, and legal purposes of the LUNA Study, in accordance with the Protection of Personal Information Act (POPIA) and applicable institutional requirements. Participants may withdraw their authorization at any time; however, data collected prior to withdrawal may continue to be used and shared. Requests must be made for legitimate scientific, regulatory, or ethical purposes related to the LUNA Study. Data will only be shared with authorized individuals or entities (e.g., regulators, ethics committees, or approved collaborators) who have a clear need to access the information. All recipients must comply with the Protection of Personal Information Act (POPIA) and any applicable institutional data protection policies. Only the minimum necessary data required to achieve the intended purpose will be shared. Where possible, data will be de-identified or anonymized prior to sharing to protect participant confidentiality. Recipients may be required to enter into a data sharing or confidentiality agreement. Access will not be granted if it conflicts with participant consent, legal requirements, or ethical obligations
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information