WithdrawnNot Applicable

Study to Evaluate the Effectiveness and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels

Stopped: Sponsor decision

Spain0Started 2019-11-14

Plain-language summary

The purpose of this study is to evaluate the effectiveness of Libicare® in the sexual desire and arousal at 12 weeks in peri or postmenopausal women aged between 40 and 60 years old with low sexual desire and arousal compared with active control.

Who can participate

Age range

45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female aged between 40 and 60 years old.
. Healthy peri or postmenopausal women.
. Body Mass Index (BMI) between 18,5-29,9.
. Female with low sexual desire and low arousal with a score ≤26.55 on the questionnaire Female Sexual Function Index (FSFI) .
. Patients who signed the Informed Consent Form.

Exclusion criteria

. Female with uncontrolled thyroid function.
. Female with severe genital pain (vaginism, stopping intercourse because of severe pain).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evolution of sexual desire and arousal

Timeframe: 12 weeks

Trial details

NCT IDNCT04188600

SponsorProcare Health Iberia S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-30

View on ClinicalTrials.gov More Female Sexual Interest/Arousal Disorder trials