- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00796133
A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women
16. april 2015 opdateret af: Population Council
This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
18
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Santiago, Chile
- Instituto Chileno de Medicina Reproductiva
-
-
-
-
-
Santo Domingo, Dominikanske republik
- Profamilia
-
-
-
-
California
-
Los Angeles, California, Forenede Stater, 90033
- Women's and Children's Hospital; LA County/USC Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Woman is between 18 and 40 years of age
- Has intact uterus and ovaries
- Has regular menstrual cycles of 25-35 days duration
- Able to comply with the protocol, including frequent blood sampling, and lives within the catchment area of the clinic
- Understands the study procedures and agrees to participate in the study by giving written informed consent
- Able to use non-hormonal, double-barrier contraceptives (e.g. condoms and diaphragm) with every act of intercourse, or has been sterilized with tubal ligation, or only male partner has been sterilized with vasectomy
- Progesterone >10 nmol/L in at least one sample in the lead-in cycle
Exclusion Criteria:
- All contraindications to OC use including
- Thrombophlebitis or thromboembolic disorders
- Past history of deep vein thrombophlebitis or thromboembolic disorders
- Past or current cerebrovascular or coronary artery disease
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- Hepatic adenomas or carcinomas
- Woman has a history of headaches with focal neurological symptoms
- Known or suspected pregnancy
- Aged >35 and smoker
- BMI >29
- Positive urine pregnancy test at the screening or baseline visit
- Desired pregnancy within the duration of the study
- Known hypersensitivity to progestins
- Known hypersensitivity to estrogen
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities
- In accordance with the Bethesda system of classification Women with a current abnormal Pap smear suggestive of high-grade pre cancerous lesion(s), including HGSIL, are excluded
- Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated with colposcopy and biopsy and no evidence of a lesion with a severity >CIN I is present and/or endocervical curettage is negative
- Women with a biopsy finding of CIN I should have follow up for this finding per standard of care; women are excluded if treatment is indicated In accordance with other Pap class systems
- Women with high grade dysplasia are excluded
- Women with low grade dysplasia or CIN I interpretation on Pap smear may participate based on investigator discretion in accordance with local standard of care
- Breastfeeding
- Cancer (past history of any carcinoma or sarcoma)
- History of a significant psychiatric disorder, including severe depression.
- Chronic or acute liver or renal disease
- Hypertension-- controlled by medication or defined by diastolic BP 85 mm Hg or systolic BP 135mm Hg after 15 minutes rest
- Dermatitis, psoriasis or other severe skin disorder
- Known or suspected alcoholism or drug abuse
- Clinically significant abnormalities of laboratory safety tests
- Chronic disease or history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject
- Woman is participating or has participated in another clinical study (involving an investigational drug) within one month prior to enrollment.
- Use of injectable contraceptives during the previous 3 months (e.g. cyclofem) or 9 months (e.g. DMPA)
- Use of oral contraceptives within the past 1 month
- Use of concomitant drugs that may interact with the study drugs
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 1
0.5 ml of NES/E2 equaling 0.45 g and contains 1.5 mg NES/0.5 mg E2
|
Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles.
The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES.
Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively.
The doses of Estradiol will also be tailored to the 3 formulations.
|
Aktiv komparator: 2
1.0 ml of NES/E2 gel equaling 0.9 g and contains 3.0 mg NES/1.0 mg E2
|
Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles.
The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES.
Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively.
The doses of Estradiol will also be tailored to the 3 formulations.
|
Aktiv komparator: 3
1.5 ml of NES/E2 gel equaling 4.5 mg NES/1.5 mg E2
|
Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles.
The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES.
Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively.
The doses of Estradiol will also be tailored to the 3 formulations.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine with ultrasound scan (USS) measures and serum progesterone (P) assessment the lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles
Tidsramme: Subjects will remain in the study for approximately 8 months
|
Subjects will remain in the study for approximately 8 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine with USS and E2 serum levels the dose that can suppress follicle growth and replace estradiol at the physiological early follicular phase level
Tidsramme: Subjects will remain in the study for approximately 8 months
|
Subjects will remain in the study for approximately 8 months
|
Evaluate the correlation of NES and E2 serum levels with the percentage of ovulation suppression
Tidsramme: Subjects will remain in the study for approximately 8 months
|
Subjects will remain in the study for approximately 8 months
|
Evaluate the safety and tolerability of the formulations
Tidsramme: Subjects will remain in the study for approximately 8 months
|
Subjects will remain in the study for approximately 8 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2008
Primær færdiggørelse (Faktiske)
1. januar 2014
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
21. november 2008
Først indsendt, der opfyldte QC-kriterier
21. november 2008
Først opslået (Skøn)
24. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Population Council #427
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med NES/E2 gel
-
Health DecisionsEunice Kennedy Shriver National Institute of Child Health and Human Development...Afsluttet
-
Health DecisionsEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereUkendtKvindelig prævention | Sunde kvinderForenede Stater
-
Mondelēz International, Inc.Provident Clinical ResearchAfsluttetType 2 diabetes mellitusForenede Stater
-
University of NebraskaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Afsluttet
-
DiaSorin Molecular LLCAfsluttetCoronavirussygdom 2019 | Influenza A | Influenza type BAustralien
-
Genexine, Inc.Afsluttet
-
Organon and CoAfsluttet
-
Akdeniz UniversityAfsluttetVarighed af østrogenadministrationKalkun
-
BayerAfsluttetOsteoporose, postmenopausalJapan
-
BayerAfsluttetOsteoporose, postmenopausalJapan