How common are mood and sexual side-effects from combined oral contraceptives?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000925-30-SE

Enrollment

300

Registered

2013-03-20

Start date

2013-05-04

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy women MedDRA version: 14.1 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Zoely Product Name: Zoely Pharmaceutical Form: Capsule INN or Proposed INN: Estradiol Other descriptive name: ESTRADIOL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 -35 years Healthy according to self-report Informed consent Accept to use barrier contraception during the study or has cupper IUD or has been sterilized Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Current pregnancy or delivery within 6 months Systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg at screening BMI > 30 kg/m2 Prior history of venous thromboembolism or first degree relatives with history of venous thromboembolism Known predisposition for venous or arterial thromboembolism Prior or ongoing angina pectoris, TIA, myocardial infarction or stroke Myocardial infarction or stroke in first degree relatives Prior reproductive cancer (breast, uterus, cervical) Prior or ongoing pancreatitis Severe and ongoing liver disease or tumor. Migraine with aura Diabetes with known arterial disease Severe dyslipidemia Sensitivity to any of the active components of the investigated product

Design outcomes

Primary

Measure	Time frame
Main Objective: to prospectively estimate the prevalence of mood and sexual side effects in combined oral contraceptives users to compare the severity of mood and sexual side effects between combined oral contraceptives users and placebo users ;Secondary Objective: to investigate risk factors for these side-effects by taking previous psychiatric history, personality traits, baseline mood and genetic factors into account.; Primary end point(s): 1. Summarized negative mood scores on the Daily Rating of Severity of Problem (DRSP) scale during treatment cycle three 2. McCoy female sexuality questionnaire (MFSQ) during treatment cycle three ;Timepoint(s) of evaluation of this end point: Pretreatment and during the last (third) treatment cycle	—

Measure

Time frame

Main Objective: to prospectively estimate the prevalence of mood and sexual side effects in combined oral contraceptives users to compare the severity of mood and sexual side effects between combined oral contraceptives users and placebo users ;Secondary Objective: to investigate risk factors for these side-effects by taking previous psychiatric history, personality traits, baseline mood and genetic factors into account.; Primary end point(s): 1. Summarized negative mood scores on the Daily Rating of Severity of Problem (DRSP) scale during treatment cycle three 2. McCoy female sexuality questionnaire (MFSQ) during treatment cycle three ;Timepoint(s) of evaluation of this end point: Pretreatment and during the last (third) treatment cycle

—

Secondary

Measure	Time frame
Secondary end point(s): Number of women with clinically relevant worsening of mood or sexual function. ;Timepoint(s) of evaluation of this end point: Pretreatment and during the last (third) treatment cycle	—

Countries

Sweden

Contacts

Public ContactInger Sundström Poromaa

Uppsala University

inger.sundstrom@kbh.uu.se46186115764

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026