A mono-centre, non-comparative clinical trial on the inhibition of ovulation with LNG POP (Levonorgestrel tablet) during three 28-day cycles with continuous treatment and intentional intake errors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

SocraTec R&D Concepts in Drug Research and Development GmbH

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Female

Therapeutic area

Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Trial duration

2 Jul 2025 → 14 Apr 2026

Decision date (initial)

2025-06-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Navad Life Sciences Pte Ltd. (Singapore)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

To investigate if ovulation inhibition with LNG-POP is maintained in spite of scheduled delays in tablet intake.

Conditions and MedDRA coding

Investigation of ovulation inhibition after intentional IMP intake errors for indication of contraception

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Federal Institute For Drugs And Medical Devices

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the participants in the clinical trial
2. 2. Sex: female, premenopausal
3. 3. Age: 18 years to 35 years inclusive, at screening
4. 4. Body mass index (BMI): ≥ 18.0 kg/m² at screening
5. 5. Good state of physical and mental health based on medical, surgical and gynaecological history, physical and gynaecological examination at screening
6. 6. Non-smoker or ex-smoker for at least 3 months if aged > 30 years or moderate smoker (10 cigarettes or 2 cigars or 2 pipes per day) if aged ≤ 30 years only; questioned at screening examination
7. 7. Both ovaries visible upon transvaginal ultrasonography (TVUS); observed at screening examination
8. 8. Ovulation in the pre-treatment cycle, defined as a serum progesterone concentration > 10.0 nmol/l on cycle day 20 (±4) or 25 (±4)

Exclusion criteria 52

1. 1. Any known severe systemic disease that might interfere with the conduct of the study or the interpretation of the results
2. 2. Existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
3. 3. Existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
4. 4. Existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
5. 5. History of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders (e.g. clinically significant depression [current or in the last year])
6. 6. Acute and chronic progressive liver diseases (e.g. disturbances of the bilirubin excretion of the bile [Dubin-Johnson and Rotor syndromes], disturbances of the bile secretion, disturbances in the bile flow, idiopathic icterus or pruritus during a previous pregnancy or estrogen-progestogen treatment)
7. 7. Presence or history of liver tumours (benign or malignant)
8. 8. Existing or previous hepatic disease as long as liver function values have not returned to normal
9. 9. Existing or history of pancreatitis, if associated with severe hypertriglyceridemia
10. 10. Presence or history of venous or arterial thromboembolic diseases (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) or prodromal conditions (e.g. transient ischemic attack, angina pectoris), cerebrovascular accident
11. 11. Presence of any hereditary or acquired predisposition for venous or arterial thrombosis that could increase the risk of any of the conditions listed in Exclusion Criterion No. 10 (e.g. APC-resistance, Antithrombin III deficiency, Protein-C and/or Protein-S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies
12. 12. Anamnestic hints for increased risk of thrombosis events in family history (e.g. any venous thromboembolic event that occurred in a close relative at a young age [≤ 50 years])
13. 13. Specific heart diseases (e.g. valvular heart disease, atrial fibrillation)
14. 14. Cardiac dysfunction (NYHA I-IV)
15. 15. Pronounced varicose veins
16. 16. History of phlebitis in combination with other risk factors for thromboembolic diseases
17. 17. Existing uncontrolled thyroid disorders
18. 18. Known diabetes mellitus
19. 19. Sickle-cell anaemia
20. 20. Known severe disturbances of lipid metabolism
21. 21. Existing or history of known or suspected malignant or premalignant diseases, regardless of the hormone status
22. 22. Abnormal, clinically significant findings which, according to the assessment of the investigator, may worsen under hormonal treatment (e.g. pemphigoid gestationis during a previous pregnancy, middle-ear deafness (otosclerosis); Sydenham’s chorea, porphyria, systemic lupus erythematosus, haemolytic-uremic syndrome)
23. 23. Known hypersensitivity to any ingredients of the study medication (active ingredients used or to constituents of the pharmaceutical preparations), (e.g. participants with rare hereditary problems or galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption)
24. 24. Participants with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
25. 25. Systolic blood pressure < 90 or > 139 mmHg
26. 26. Diastolic blood pressure < 60 or > 89 mmHg
27. 27. Pulse rate < 50 bpm or > 90 bpm
28. 28. Clinical laboratory values out of normal range at screening unless the minor deviation from normal is judged as not relevant for the clinical trial by the investigator
29. 29. ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine > 0.1 mg/dL ULN (limit of > 0.1 mg/dL correspondents to of > 9 µmol/l ULN).
30. 30. Positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or anti-HCV-test
31. 31. Diagnosis of latest PAP smear: findings classified higher than score II (Munich Nomenclature III)
32. 32. Other diseases: migraine with neurologic symptoms (complicated migraine), undiagnosed vaginal bleeding, manifest kidney disease with impaired renal function, worsening of epilepsy or chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) under hormonal treatment
33. 33. Acute or chronic diseases which may interfere with the aims of the clinical trial
34. 34. History of or current drug, alcohol or medicine abuse (e.g. laxatives)
35. 35. Participants who are on a diet which could affect the pharmacokinetics of the active ingredient
36. 36. Blood donation or other blood loss more than 400 ml after individual enrolment (signed informed consent) of the participant
37. 37. Participation in another clinical study or administration of any investigational medicinal product within 1 cycle prior to start of the pre-treatment cycle
38. 38. Surgery scheduled in the study period (minor surgical procedures [e.g. day case surgery] are permissible)
39. 39. Treatment with any systemically available medication within 2 weeks prior to start of the pre-treatment cycle which might interfere with pharmacodynamics, pharmacokinetics or safety of the IMPs (see chapter 13.2.1 of the clinical trial protocol)
40. 40. Use of any hormonal contraception preceding the pre-treatment cycle as follows: shortly acting hormonal contraceptives as oral, patch, ring or intra uterine system within one cycle; injectable (intramuscularly or subcutaneously) within 10-month (three-month treatment duration), 6-month (two-month treatment duration) or 3-month (one-month treatment duration)
41. 41. In case of washout phase, if no spontaneous menses started within 46 days after stop of short-acting hormonal contraceptive
42. 42. Participants with known cycle irregularities during the last year, prior to screening examination, if not caused by hormonal contraceptives
43. 43. Positive pregnancy test at screening examination or any time during the study
44. 44. Pregnant or lactating women (less than 3 cycles following delivery, abortion, or lactation before start of pre-treatment cycle)
45. 45. In case of heterosexual activity, female participants who do not agree to apply a barrier method for contraception (e.g. male condom) or hetero-sexual abstinence from screening onward until the final visit
46. 46. Participants, who actually desire to be pregnant
47. 47. Non-availability of prompt access to eDiary at any time
48. 48. Participants suspected or known not to follow instructions
49. 49. Participants who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
50. 50. Participant is a dependent person, e.g. a relative, family member, or member of the investigator’s staff
51. 51. Participants who are in custody by order of an authority or a court of law
52. 52. Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant’s safety

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Ovulation under treatment (Ovulation during treatment is defined as a Hoogland-Skouby score (HSS) 5 or 6 in combination with fulfilment of Landgren criterion (P concentration >16.0 nmol/l during at least 5 consecutive days)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

SocraTec R&D Concepts in Drug Research and Development GmbH

Sponsor organisation

SocraTec R&D Concepts in Drug Research and Development GmbH

Address

Im Setzling 35, Bommersheim Bommersheim

City

Oberursel (Taunus)

Postcode

61440

Country

Germany

Scientific contact point

Organisation

SocraTec R&D Concepts in Drug Research and Development GmbH

Contact name

Scientific Director of the clinical trial

Public contact point

Organisation

SocraTec R&D Concepts in Drug Research and Development GmbH

Contact name

Project Manager

Third parties 4

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications