How the body processes doses of hormone and NSAID drugs
| ISRCTN | ISRCTN97110708 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97110708 |
| Sponsor | FHI 360 |
| Funder | CIFF IP Co Limited |
- Submission date
- 24/02/2026
- Registration date
- 30/03/2026
- Last edited
- 07/10/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
This study is investigating a new “on demand” birth control pill that combines a hormone with an NSAID. Hormones can disrupt ovulation (the process leading to the ovaries to produce an egg) when taken around the time of sex, but they don't work very well on their own for this purpose. NSAIDs may also help block ovulation and could make the hormone more effective. This study will look at how each drug works in the body, alone and together, when taken just before ovulation.
Who can participate?
Healthy female volunteers aged 18 to 40 years.
What does the study involve?
This study has two parts. In Part 1, people take part in a three‑period, randomised cross‑over trial. This means each participant will receive three different one‑time treatments, but in different orders. The order is randomly assigned by a secure computer system, and participants only find out which treatment they will get right before they take it. All treatments are given in the clinic by trained study staff.
The four possible treatments are:
A single 15 mg tablet of an NSAID.
A single 1.5 mg tablet of a hormone.
Both taken together as two separate tablets.
A single study tablet that combines both into one pill.
Each participant in Part 1 will receive three of these interventions in a sequence determined at random.
In Part 2, a smaller group of participants will take part in a pharmacokinetic assessment of the bilayer study tablet (the combined pill). This involves measuring how the body absorbs, distributes, and processes the medication after it is taken.
What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration
Where is the study run from?
Profamilia, Dominican Republic.
When is the study starting and how long is it expected to run for?
April 2026 to April 2027
Who is funding the study?
CIFF IP Co Limited, UK.
Who is the main contact?
Vivian Brache, vbrache@profamilia.org.do
Contact information
Public
FHI 360
359 Blackwell Street
Suite 200
Durham
27701
United States of America
| Phone | +1 2028848200 |
|---|---|
| dkozlowski@fhi360.org |
Scientific
FHI 360
359 Blackwell Street
Suite 200
Durham
27701
United States of America
| Phone | +1-919-321-3331 |
|---|---|
| vhalpern@fhi360.org |
Principal investigator
Investigaciones Biomédicas de Profamilia, Nicolas de Ovando esq. Calle 16
Santo Domingo
10401
Dominican Republic
| Phone | +1 (809) 681-8357 |
|---|---|
| vbrache@profamilia.org.do |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Crossover |
| Purpose | Treatment |
| Scientific title | Pharmacodynamic and pharmacokinetic responses to a hormone and NSAID, administered individually and in combination |
| Study acronym | POCP |
| Study objectives | Evaluate and compare the effect of a hormone and NSAID on ovarian function when administered in the advanced follicular phase individually and in combination |
| Ethics approval(s) |
Approved 24/03/2026, PROFAMILIA Ethics Committee (Dominican Association for Family Welfare, Inc., 160 Socorro Sánchez Street, Gazcue, P.O. Box 1053, Santo Domingo, -, Dominican Republic; +1 809-689-0141; info@profamilia.org.do), ref: 2402074 |
| Health condition(s) or problem(s) studied | Evaluation of a hormone and NSAID on ovarian function in healthy female volunteers |
| Intervention | Current interventions as of 28/09/2026: 3-period, randomized, cross-over trial (Part 1), followed by a pharmacokinetics assessment of the a combined product in a subset of participants (Part 2) Intervention 1: One-time oral dose of a single tablet of an NSAID (a non-steroidal anti-inflammatory drug) provided in the clinic by a trained study investigator. Intervention 2: One-time oral dose of a single tablet of a hormone provided in the clinic by a trained study investigator. Intervention 3: One-time oral dose of an NSAID and a hormone provided in the clinic by a trained study investigator. Intervention 4: One-time oral dose of the single study tablet (combined product) provided in clinic by a trained study investigator. Randomization Enrolled and consented participants will be randomized to one of 6 treatment sequences in this three-period crossover trial. Each participant’s treatment sequence will be determined based on a randomly permuted block design generated using a validated software program. Treatment sequences will be concealed using a web-based interactive system, with each participant's treatment revealed immediately prior to dosing. _____ Previous interventions: 3-period, randomized, cross-over trial (Part 1), followed by a pharmacokinetics assessment of the a combined product in a subset of participants (Part 2) Intervention 1: One-time oral dose of a single tablet of an NSAID (a non-steroidal anti-inflammatory drug) 15mg provided in the clinic by a trained study investigator. Intervention 2: One-time oral dose of a single tablet of a hormone 1.5mg provided in the clinic by a trained study investigator. Intervention 3: One-time oral dose of an NSAID 15mg and a hormone 1.5mg provided in the clinic by a trained study investigator. Intervention 4: One-time oral dose of the single study tablet (combined product) provided in clinic by a trained study investigator. Randomization Enrolled and consented participants will be randomized to one of 6 treatment sequences in this three-period crossover trial. Each participant’s treatment sequence will be determined based on a randomly permuted block design generated using a validated software program. Treatment sequences will be concealed using a web-based interactive system, with each participant's treatment revealed immediately prior to dosing. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Hormone, NSAID |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/04/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Is 18 to 40 years of age (inclusive) 2. Is in good general health based on results of physical examination, medical history and vital signs tests 3. Is able and willing to provide informed consent and follow all trial requirements 4. Has regular menstrual cycles (24-35 days) 5. Has ovulatory cycle during the screening 6. Has had tubal ligation 7. Has a body mass index of 18.0-35.0 (kg/m2) 8. Has hemoglobin ≥10.0 g/dl |
| Key exclusion criteria | 1. Recently (within the last 3 months) or currently pregnant 2. Is currently lactating 3. Has more than one risk factor for cardiovascular disease (such as smoking, diabetes, hypertension, and known dyslipidemias) 4. Has hypertension with systolic blood pressure ≥160 mmhg, and/or diastolic blood pressure ≥100 mmhg 5. Has hypertension with vascular disease 6. Has a history of coronary artery bypass graft (CABG) surgery 7. Currently has and/or has a history of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) or a hereditary or acquired predisposition or elevated risk for venous thrombosis 8. Currently has or has a history of ATE (myocardial infarction, stroke, or peripheral arterial disease) or a hereditary or acquired predisposition or elevated risk for arterial thrombosis 9. Has a history of cerebrovascular bleeding, gastrointestinal bleeding, or other bleeding disorders 10. Has systemic lupus erythematosus 11. Has migraine with aura 12. Has unexplained vaginal bleeding 13. Has undiagnosed mass in the breast 14. Currently has and/or has a history of breast cancer 15. Currently has cervical cancer (including CIN 3) 16. Has known hypersensitivity to hormonal medications 17. Has known hypersensitivity to non-steroidal anti-inflammatory drugs(NSAIDS) (e.g., anaphylactoid reactions and serious skin reactions) 18. Has a history of asthma, nasal polyps, angioneurotic oedema or urticaria after taking aspirin or other NSAIDS 19. Has a history of recurrent peptic ulcer, perforation or gastrointestinal bleeding, related to previous NSAIDS therapy 20. Uses of any investigational or prohibited drugs per protocol 21. Has liver cirrhosis 22. Currently has and/or has a history of liver tumors (benign or malignant) 23. Knows of active liver disease 24. Knows of active renal disease 25. Plans to move to another location in the next 8 months that would interfere with trial participation 26. Has previously participated in this trial 27. Is currently participating in another clinical trial 28. Has any condition (social or medical) which in the opinion of the site investigator would make trial participation unsafe, would interfere with adherence to trial requirements or complicate data interpretation |
| Date of first enrolment | 06/04/2026 |
| Date of final enrolment | 30/12/2026 |
Locations
Countries of recruitment
- Dominican Republic
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
07/10/2026: The Date of final enrolment was changed from 30/10/2026 to 30/12/2026.
28/09/2026: The interventions were changed.
30/03/2026: Study’s existence confirmed by the PROFAMILIA Ethics Committee, Dominican Republic.
