Brain effects of hormonal contraceptives.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Uppsala

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

18 Mar 2024 → 8 Jun 2025

Decision date (initial)

2024-01-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Gedeon Richter, unrestricted research grant

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To establish if the combined hormonal contraceptives E4/DRSP and EE/LNG have differential effects on brain structure and function.

Secondary objectives 2

1. Change in quality of life
2. Change in depressive and anxiety symptoms

Conditions and MedDRA coding

Contraception

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. – be essentially healthy
2. – in need of contraception, i.e. sexually active
3. – be a woman between 18-35 years of age (i.e. ≥18 and <36 years)
4. – have a regular menstrual cycle (25-31 days) in the opinion of the investigator

Exclusion criteria 26

1. – History of venous thromboembolism (VTE), or first-degree relatives with a history of VTE
2. – Genetic or acquired predisposition for venous or arterial thrombosis including activated protein C resistance, anti-thrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia or anti-phospholipid antibodies
3. – Major planned surgery, requiring immobilization.
4. – High risk for VTE due to multiple risk factors
5. – Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening
6. – Previous or ongoing atherosclerosis such as coronary artery disease, myocardial infarction, stroke or transient ischemic attack
7. – BMI > 30.0 kg/m2
8. – Parents diagnosed with myocardial infarction or stroke (before the age of 55 in father and before the age of 65 in mother)
9. – Previous hormone-sensitive cancer, like breast cancer, endometrial cancer or ovarian cancer
10. – Previous or ongoing pancreatitis
11. – Ongoing severe liver disease, or liver tumor
12. – Renal insufficiency or severe kidney disease
13. – Type 1 diabetes with vascular complications
14. – Severe dyslipidemia
15. – Migraine with aura
16. – Vaginal bleeding of unknown origin
17. – Oral cortisone treatment during the previous 3 months.
18. – Treatment with antidepressive- or antipsychotic drugs or other psychopharmaceuticals during the previous 3 months.
19. – Ongoing psychiatric disease
20. – Premenstrual dysphoric syndrome according to daily symptom ratings on the DRSP scale
21. – Severe medical conditions in the opinion of the investigator that may interfere with compliance to treatment or study procedures
22. – Breast-feeding, pregnancy or plans of a pregnancy during the study period
23. – Concurrent participation in any other clinical trial
24. – Hearing impairments or visual impairment (> 5 degrees myopic/hyperopic or profound astigmatism)
25. – Profound fear of confined spaces
26. – Other contraindications for magnetic resonance imaging

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline to treatment in grey matter volume grey matter surface and gyrification, white matter integrity and connectivity (DTI), resting state activity and reactivity during emotion processing

Secondary endpoints 3

1. Change in DRSP score between baseline and treatment
2. Change in Quality of Life between baseline and treatment
3. Change in depressive symptoms and anxiety symptoms from baseline

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Uppsala

Sponsor organisation

Region Uppsala

Address

Storgatan 27, Uppsala Domkyrkofors. Uppsala Domkyrkofors.

City

Uppsala

Postcode

753 31

Country

Sweden

Scientific contact point

Organisation

Region Uppsala

Contact name

Inger Sundström Poromaa

Public contact point

Organisation

Region Uppsala

Contact name

Department of Obstetrics and Gynecology

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

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

Application history

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