A Phase 4 interventional study of Alprazolam 0.5 mg in Gynecologic Disease and Anxiety Disease, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by Central Hospital, Nancy, France · Phase 4, Interventional, and Treatment
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Among 10 studies in Genital Diseases, Female with a site in France — 2 open to participants now, 2 under way, none of them phase 3. Genital Diseases, Female · France.
Among the 10 studies in Genital Diseases, Female with a site in France, this one is the only one that started in 2018, is the only one in phase 4, and was the 4th registered.
161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.
Browse Genital Diseases, Female studies →2 of the 10 studies in Genital Diseases, Female with a site in France are open now. Recruiting first, the newest first:
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18–60 · Women only
ZIWIG · Sites in France
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 21 Genital Diseases, Female studies recruiting now, 10 (48%) set no upper age limit and 11 (52%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 128 is above the median of 78 across 119 interventional studies indexed under Genital Diseases, Female.
Median enrollment 92 across the 8 interventional studies, 1,655 across the 2 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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2 of 10 have an industry lead sponsor. The 10 most frequent:
Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
Central Hospital, Nancy, France has 2 studies filed under Genital Diseases, Female — fewer than ten, so there is no comparison to draw.
2 of the studies in Genital Diseases, Female with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06392997ZIWIGEvaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology | 2026-12 |
| NCT06615843Assistance Publique - Hôpitaux de ParisRandomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up | 2027-06-30 |
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Among the 10 studies in Genital Diseases, Female with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention: hypnosis session the eve of the surgery
Drug: Alprazolam 0.5 mg
alprazolam 0,5 mg the eve and the morning of the surgery
Drug: Alprazolam 0.5 mg
alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session
Also known as: hypnosis
Preoperative Anxiety score evaluated by STAI-Y
evaluated by STAI-Y self-administered questionary
Time frame: before surgery (day 2_before)
Anxiety score evaluated by analogue visual scale
evaluated by analogue visual scale (EVA 0 to 10)
Time frame: at inclusion visit (day 1), before surgery (day 2_before), after surgery (day 2_after), 24 h after the surgery (day 3)
sleep quality evaluated by EVA scale
evaluated by EVA scale (0 to 10)
Time frame: day 2_before and the day 3
patient satisfaction score evaluated by EVA scale
evaluated by EVA scale (0 to 10)
Time frame: day 3
analysis of salivary amylase
salivary amylase
Time frame: day 1 and day2_before
postoperative fatigue evaluated by EVA scale
evaluated by EVA scale (0 to 10)
Time frame: day 3
Intraoperative morphine and hypnotics drugs Consumption
Consumption
Time frame: day 3
Incidence of nausea and vomiting
Incidence
Time frame: day 3
Score of pain measured by EVA scale
measured by EVA (0 to 10)
Time frame: day 2_after, day 2_recovery room (at the end of recovery room) and Day 3
Started Nov 2018 (actual). Primary completion is estimated for Dec 2021, 37 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alprazolam
Central Hospital, Nancy, France →