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NCT05212389
The Pill Project - Oral Contraceptive and Serotonergic Brain Signaling
NA trial testing Femicept in Major Depressive Disorder in 40 participants. Status unknown.
31 August 2024
Quick facts
| Lead sponsor | Rigshospitalet, Denmark |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 40 |
| Start date | 22 December 2021 |
| Primary completion | 31 August 2024 |
| Estimated completion | 31 August 2025 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Femicept — full drug profile →
- Placebo
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
- Sexual Behavior — all drugs for Sexual Behavior →
- Mood Disturbance — all drugs for Mood Disturbance →
- Mood Change — all drugs for Mood Change →
Sponsor
Rigshospitalet, Denmark
Who can join
Adults 18 to 22, female only, with Major Depressive Disorder or Sexual Behavior. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Large register based work has shown that starting on oral contraceptives (OCs) is associated with an increased risk of developing depressive episodes. It is not known why this is, but changes in the serotonergic brain system might play a role. Intriguingly, in cross-sectional work, the investigators have demonstrated a lower level of the serotonin 4 receptor globally in the brain of healthy women using oral contraceptives compared to non-users. The order of magnitude of this difference is comparable to what has been observed in depressed individuals relative to healthy controls. In this study, the investigators will apply a longitudinal design to determine if starting on oral contraceptives induces a reduction in the serotonin 4 receptor in healthy women and whether such changes are related to potential changes in measures of cognition as well as mood/affect and sexual desire. The study is a single-blind randomized placebo-controlled trial with a 3-month intervention paradigm of either Femicept (2nd generation combined oral contraceptive) or placebo. The investigators will include participants until 20 women have completed the study in each arm. Participants will go through an investigational program, including PET and MR brain scans and neuropsychological testing, before starting on the treatment and again during the third pill cycle. To capture changes in mood/ and sexual desire, the participants will complete daily questionnaires during the baseline menstrual cycle and during third pill cycle. A linear latent variable model will be used to evaluate if OC use induces changes in the serotonin 4 receptor level and such changes will be correlated to changes in secondary outcomes (i.e., cognitive and psychometric measures).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05212389
- Europe PMC full search
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Other Rigshospitalet, Denmark trials
Trials by the same sponsor.
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- NCT07528729 — Alcohol as a Modifiable Risk Factor for Atrial Fibrillation · NA · not yet recruiting
- NCT07511439 — Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission · Phase 4 · not yet recruiting
- NCT07467187 — Invasive Home Ventilation in Denmark · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05212389 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rigshospitalet, Denmark
- Last refreshed: 28 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05212389.
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